Tools and methods for vaginal access

ABSTRACT

Trocar components and methods of use are described, wherein the trocar components are configured to provide access to intraperitoneal space via the rectouterine pouch to surgical tools, which optionally include one or more surgical robot members. The surgical tools are optionally 5 mm or more in diameter. In some embodiments, a cannula part has a lumen sized to provide to a plurality of the surgical tools simultaneous transvaginal access to the intraperitoneal space via the rectouterine pouch. In some embodiments, an incision sized to receive a distal aperture of the cannula is created, optionally using one or two dilators. The dilators are sized to create (optionally starting from a puncture by a needle 2 mm in diameter or less) an oblong aperture. In some embodiments, the oblong aperture is at least twice as wide across a long diameter as across a short diameter.

RELATED APPLICATIONS

This application claims the benefit of priority of U.S. ProvisionalPatent Application No. 62/549,097 filed on Aug. 23, 2017; U.S.Provisional Patent Application No. 62/549,078 filed on Aug. 23, 2017;U.S. Provisional Patent Application No. 62/558,460 filed on Sep. 14,2017; and U.S. Provisional Patent Application No. 62/558,469 filed onSep. 14, 2017; the contents of which are incorporated herein byreference in their entirety.

This application is also a part of a set of filings which are co-filed,co-pending and co-assigned:

U.S. patent application Ser. No. 16/109,891 filed on Aug. 23, 2018,entitled “TOOLS AND METHODS FOR VAGINAL ACCESS”;

PCT Patent Application No. PCT/IL2018/050934 filed on Aug. 23, 2018,entitled “TOOLS AND METHODS FOR VAGINAL ACCESS”;

Canadian Patent Application No. 3,015,084 filed on Aug. 23, 2018,entitled “TOOLS AND METHODS FOR VAGINAL ACCESS”;

U.S. patent application Ser. No. 16/109,893 filed on Aug. 23, 2018, nowU.S. Pat. No. 10,736,658, entitled “TOOLS AND METHODS FOR VAGINALACCESS”;

Canadian Patent Application No. 3,015,089 filed on Aug. 23, 2018,entitled “TOOLS AND METHODS FOR VAGINAL ACCESS”;

U.S. patent application Ser. No. 16/109,880 filed on Aug. 23, 2018, nowU.S. Pat. No. 10,849,654, entitled “TOOLS AND METHODS FOR VAGINALACCESS”; and

U.S. patent application Ser. No. 16/109,879 filed on Aug. 23, 2018, nowU.S. Pat. No. 10,869,692, entitled “TOOLS AND METHODS FOR VAGINALACCESS”;

the disclosures of which are all incorporated herein by reference.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to the fieldof intraperitoneal surgery and more particularly, to devices and methodsfor laparoscopic access to the intraperitoneal space.

Culdoscopy is an endoscopic procedure performed to examine therectouterine pouch and pelvic viscera by the introduction of aculdoscope through the posterior vaginal wall. The culdoscope may be amodified laparoscope. A trocar is first inserted through the vagina intothe posterior cul-de-sac, the space behind the cervix, allowing then theentry of the culdoscope. Due to the position of the patient, intestinesfall away from the pelvic organs which can then be inspected. Conditionsdiagnosable by culdoscopy include tubal adhesions (causing sterility),ectopic pregnancy, and salpingitis. Culdoscopy allows the performance ofminor procedures such as tubal sterilization.

SUMMARY OF THE INVENTION

There is provided, in accordance with some embodiments of the presentinvention. a stepped dilator for use with a trocar kit to provideintraperitoneal access via a body recess, comprising: a dilator bodyhaving a longitudinal axis in proximal to distal direction; a firsttapered region of the dilator body tapering narrower toward a distal endof the dilator body; a second tapered region of the dilator bodytapering narrower in a distal direction, located proximally to the firsttapered region, and separated from the first tapered region by anisolating region.

In some embodiments, the isolating region comprises a region of constantcross-section perpendicular to the longitudinal axis extending betweenthe first tapered region and the second tapered region.

In some embodiments, the isolating region comprises a region with nocross-section perpendicular to the longitudinal axis larger in anydirection than the largest cross-section perpendicular to thelongitudinal axis of the first tapered region.

In some embodiments, the isolating region is at least 3 mm long.

In some embodiments, the isolating region is no more than 20 mm long.

In some embodiments, the isolating region is between 5-15 mm long.

In some embodiments, a whole tapering extent of at least one of thefirst tapered region and the second tapered region tapers between itssmallest cross-sectional area and its largest cross-sectional areaperpendicular to the longitudinal axis over a longitudinal distance of15 mm or less.

In some embodiments, through the tapering extent of at least one of thefirst tapered region and the second tapered region, a diameter of thestepped dilator perpendicular to the longitudinal axis increases by atleast 7.5 mm.

In some embodiments, a cross-section with the largest cross-sectionalarea of the first tapered region perpendicular to the longitudinal axishas at least one axis of about 10 mm or longer.

In some embodiments, a distal tip of the first tapered region comprisesa front surface aperture of 4 mm2 or less, and expands in a distaldirection from the front surface aperture through a radius of curvatureof at least 2.5 mm.

In some embodiments, the front surface aperture is an aperture of aninner lumen sized to allow partial advancement of a trocar needle havinga diameter less than or equal to about 2 mm in a longitudinal directionthrough the aperture.

In some embodiments, the cross-section of the first tapered regionhaving the largest cross-sectional area perpendicular to thelongitudinal axis has at least one axis of about 7.5 mm or less.

There is provided, in accordance with some embodiments of the presentinvention: a kit comprising the stepped dilator described above, alongwith a handle and a trocar needle; wherein the stepped dilator andhandle together define a lumen sized to accept passage the trocar needlefrom a proximal end of the handle to a distal tip of the steppeddilator.

In some embodiments, the trocar needle is provided with a handleextending at least 5 cm past a proximal end of the handle when a distaltip of the trocar needle is advanced 5 mm past the distal tip of thestepped dilator.

In some embodiments, the trocar needle is provided with a dull-tipped,inner, spring-loaded stylet to act as a Veress needle having an extendedposition and a collapsed position; wherein the stylet comprises a bluntend extending past a sharp tip of the trocar needle in the extendedposition and preventing the sharp tip from injuring tissue; and whereinthe stylet moves to the collapsed position upon sufficient longitudinalforce being exerted so that it no longer extends pas the sharp tip,allowing the sharp tip can operate to penetrate tissue.

In some embodiments, provided with a stopper device is configured toresist advancing the distal tip of the trocar needle more than 5 mmbeyond the distal tip of the stepped dilator.

In some embodiments, a cross-section with the largest cross-sectionalarea of the second tapered region perpendicular to the longitudinal axishas at least one axis of about 21 mm or longer.

There is provided, in accordance with some embodiments of the presentinvention. a cannula to provide intraperitoneal access across a wall ofa body recess, wherein a cross-section of an inner lumen of the cannulatransverse to a longitudinal axis of the cannula has a long and a shortaxis; and wherein the long axis is at least twice as long as the shortaxis.

In some embodiments, the short cross-section axis is between 5 mm and 10mm.

In some embodiments, the long cross-section axis is between 10 mm and 30mm.

In some embodiments, a lumenal wall defining the transversecross-section of the cannula comprises straight sections on oppositesides of the transverse cross-section.

In some embodiments, the straight sections are interconnected throughcurved sections.

In some embodiments, the cannula is at least 5 cm long.

In some embodiments, an edge defining an aperture at a distal end of thecannula comprises a first edge portion extending along one side of theaperture, and a second edge portion extending along another side of theaperture, wherein the first edge portion extends along a side moredistal along the longitudinal axis than the second edge portion.

In some embodiments, the first and second edge portions extend alongopposite sides of the aperture.

In some embodiments, the first edge portion and the second edge portionextend along the long cross-section axis.

In some embodiments, the cannula comprises a handle extending at least10 cm from a proximal end of the cannula.

There is provided, in accordance with some embodiments of the presentinvention. a cannula for use with a trocar to provide intraperitonealaccess via a body recess, wherein an edge defining an aperture at adistal end of the cannula comprises a first edge portion extending alongone side of the aperture, and a second edge portion extending alonganother side of the aperture, wherein the first edge portion extendsalong a side more distal along the longitudinal axis than the secondedge portion.

In some embodiments, the first edge portion is positioned at least 5 mmmore distally than the second edge portion.

In some embodiments, the first edge portion and the second edge portioneach comprise respective a straight portion.

There is provided, in accordance with some embodiments of the presentinvention. a method of using a cannula to provide intraperitoneal accessto a body cavity via a body recess, comprising: inserting a distal endof the cannula into a dilated aperture of a rectouterine pouch viatransvaginal access; wherein an edge defining an aperture at the distalend of the cannula comprises a first edge portion extending along oneside of the aperture, and a second edge portion extending along anopposite side of the aperture, and the first edge portion is positionedmore distally along the cannula and from the dilated aperture than thesecond edge portion; and wherein the cannula is inserted so that theaperture at the distal end of the cannula is oriented to open toward theside of the second edge portion and facing toward a rectum adjacent tothe rectouterine pouch.

In some embodiments, the method comprises inserting a flexible roboticarm through the cannula and into the rectouterine pouch, so that itexits the aperture in a direction oriented away from the rectum.

In some embodiments, the inserting a distal end of the cannula into therectouterine pouch comprises sliding the cannula over an outer dilator;the outer dilator has a tapered distal insertion end sized and shaped tofittingly slide over an inner dilator having a tapered distal insertionend with a rounded tip; the cannula slides fittingly over the outerdilator; and at least the outer dilator is inserted into therectouterine pouch via transvaginal access.

In some embodiments, the method comprises sliding the cannula over theouter dilator while the inner dilator remains within the outer dilator.

In some embodiments, the inserting a distal end of the cannula into therectouterine pouch comprises sliding the cannula over a stepped dilator;the stepped dilator has a tapered distal insertion end with a roundedtip, a second tapered region, and an isolating region between the secondtapered region and the tapered distal insertion end; the cannula slidesfittingly over the stepped dilator; and the dilator is inserted into therectouterine pouch via transvaginal access.

In some embodiments, the rounded tip has a hole sized to pass a trocarneedle having a diameter less than or equal to about 2 mm.

There is provided, in accordance with some embodiments of the presentinvention. a kit for providing intraperitoneal access via a body recess,comprising: a cannula, wherein a transverse cross-section of an innerlumen of the cannula transverse to a longitudinal axis of the cannulahas a long axis long enough to allow simultaneous insertion of at leasttwo cylindrical members, each at least 8 mm in diameter; a steppeddilator having a dilator body with: a first tapered region of thedilator body tapering narrower toward a distal end of the dilator body,and a second tapered region of the dilator body tapering narrower in adistal direction, located proximally to the first tapered region, andseparated from the first tapered region by an isolating region; and atrocar needle provided with a handle region extending past a proximalend of the inner dilator when a distal tip of the trocar needle isadvanced to the distal tip of the inner dilator.

In some embodiments, the long axis of the cannula inner lumen transversecross-section is at least 21 mm.

In some embodiments, the cannula has a short cross-sectional axis; andwherein the long cross-sectional axis is at least twice as long as theshort cross-sectional axis.

In some embodiments, the kit comprises an arm sheath for a plurality ofrobotic arms, sized to fit within the cannula, having a minimum diameterof about 10 mm, and a maximum diameter of at least twice the minimumdiameter.

There is provided, in accordance with some embodiments of the presentinvention. a method of gaining intraperitoneal access via a body recess,comprising: inserting a first stage of a stepped dilator into arectouterine pouch to widen an aperture in a wall of the rectouterinepouch; and inserting a second stage of the stepped dilator into therectouterine pouch to widen the aperture; wherein the first and secondstages of the stepped dilator each comprise a region which tapersnarrower in a distal direction, and wherein the first and second stagesof the dilator are separated by an isolating region at least 3 mm long.

In some embodiments, the method is preceded by: inserting the steppeddilator transvaginally to the wall of the rectouterine pouch; andadvancing a trocar needle from within the stepped dilator to produce theaperture in the wall of the rectouterine pouch.

In some embodiments, an inner lumen of the cannula has at least onecross-sectional axis of at least 20 mm.

In some embodiments, the inner lumen of the cannula has at least onecross-sectional axis of less than about 12 mm.

There is provided, in accordance with some embodiments of the presentinvention. a method of gaining intraperitoneal access via a body recess,comprising: inserting a camera to an intraperitoneal space with a wallof a rectouterine pouch in a field of view of the camera; illuminatingthe wall of the rectouterine pouch using an intraperitoneally positionedillumination device; selecting a position for an aperture in the wall ofthe rectouterine pouch, based on light from the illumination devicevisible from outside the rectouterine pouch; advancing a trocar needlefrom outside the rectouterine pouch to press against the selectedposition in the wall of the rectouterine pouch; verifying the positionof the trocar needle, based on one or more images from the camera withinthe intraperitoneal space; and piercing the rectouterine pouch to fromthe aperture, using the trocar needle.

There is provided, in accordance with some embodiments of the presentinvention. a kit for setting a position of a robotic arm system along alongitudinal axis of a cannula inserted to a body orifice, wherein therobotic arm system comprises a motor unit and at least one robotic armextending, when positioned, distally from the motor unit along thelongitudinal axis, the kit comprising: the cannula, including a cannulabody configured for insertion to the body orifice; a mounting block,configured for attachment to the cannula; and an assembly attached tothe mounting block and comprising a spacing arm and an aligning arm, andmovable between a stowed position and a deployed position; wherein thedeployed position of the assembly places elements of the aligning armwhere they indicate a predetermined position along the longitudinalaxis.

In some embodiments, the mounting block attaches to the cannula byconnecting to an access device having a lumen sized to fittingly acceptthe cannula therewithin.

In some embodiments, the spacing arm and the aligning arm deploy byhinging around a plurality of stopped hinges, each stopped hingedefining at least a stopped deployed position, and a stopped stowedposition.

In some embodiments, the kit further comprises: the motor unit and theat least one robotic arm extending distally from the motor unit to apredetermined distance from a stopper-receiving portion of the motorunit; wherein a distal end of the at least one robotic arm aligns with adistal end of the cannula when the at least one robotic arm is insertedto the cannula, and a stopper portion of the aligning arm contacts astopper-receiving portion of the motor unit to prevent longitudinaladvance of the motor unit.

In some embodiments, the kit comprises an arm sheath with a lumen sizedto accept the at least one robotic arm, and an outer surface sized tofit within the cannula.

There is provided, in accordance with some embodiments of the presentdisclosure, an inner dilator for use with a trocar kit to provideintraperitoneal access via a body recess, having a distal insertion endtapered over a longitudinal distance of 15 mm or less between a distaltip and a fully dilating cross-section of the inner dilator, wherein:the fully dilating cross-section of the inner dilator has at least oneaxis of about 10 mm or longer; the distal tip of the insertion endcomprises a front surface aperture of 4 mm² or less, and the distal tipof the insertion end expands in a direction along the taper from thefront surface aperture through a radius of curvature of at least 2.5 mm;and the front surface aperture is an aperture of an inner lumen sized toallow partial advancement of a trocar needle having a diameter less thanor equal to about 2 mm in a longitudinal direction through the aperture.

In some embodiments, the fully dilating cross-section of the innerdilator has at least one axis of about 7.5 mm or less.

There is provided, in accordance with some embodiments of the presentdisclosure, a kit comprising the inner dilator described above, alongwith the trocar needle, wherein the inner dilator is at least 17 cmlong, and the trocar needle is provided with a handle extending at least5 cm past a proximal end of the inner dilator when a distal tip of thetrocar needle is advanced 5 mm past the distal tip of the inner dilator.

In some embodiments, the trocar needle is provided with a dull-tipped,inner, spring-loaded stylet to act as a Veress needle, wherein thestylet, in its extended position prevents a sharp tip of the needle frominjuring tissue, but collapses upon sufficient longitudinal force beingexerted so that the sharp tip can operate to penetrate tissue.

In some embodiments, provided with a stopper device is configured toresist advancing the distal tip of the trocar needle more than 5 mmbeyond the distal tip of the inner dilator.

There is provided, in accordance with some embodiments of the presentdisclosure, a kit comprising the inner dilator described above, alongwith an outer dilator, wherein the outer dilator has a distal insertionend tapered over a longitudinal distance of 15 mm or less between adistal opening and a fully dilating cross-section of the outer dilator,wherein the fully dilating cross-section of the inner dilator has atleast one axis of about 21 mm or longer.

In some embodiments, the distal opening has an inner lumen sized tofittingly enclose the fully dilating cross-section of the inner dilator.

In some embodiments, the kit is provided with a stopper configured toresist advancing the distal tip of the outer dilator more than 15 mmbeyond the distal tip of the inner dilator.

There is provided, in accordance with some embodiments of the presentdisclosure, a trocar kit for providing intraperitoneal access via a bodyrecess, comprising: a cannula, wherein a transverse cross-section of aninner lumen of the cannula transverse to a longitudinal axis of thecannula has a long axis long enough to allow simultaneous insertion ofat least two cylindrical members, each at least 8 mm in diameter; aninner dilator at least long enough to leave an external handling regionof about 10 cm while inserted fully into a body aperture 7 cm long, andhaving a distal insertion end tapered over a longitudinal distance shortenough to reach a complete first-stage dilation within 15 mm or less ofmovement between a distal tip of 4 mm² area or less and a fully dilatingcross-section of the inner dilator, wherein the fully dilatingcross-section of the inner dilator has at least one axis about half aslong as the long axis of the cannula cross-section; a trocar needleprovided with a handle region extending past a proximal end of the innerdilator when a distal tip of the trocar needle is advanced to the distaltip of the inner dilator; and an outer dilator, wherein the outerdilator has a distal insertion end tapered over a longitudinal distanceof 15 mm or less between a distal opening sized to fittingly surroundthe fully dilating cross-section of the inner dilator, and a fullydilating cross-section of the outer dilator, wherein the fully dilatingcross-section of the outer dilator is sized to be fittingly surroundedby the inner lumen of the cannula.

In some embodiments, the long cross-sectional axis of the cannula innerlumen is at least 21 mm.

In some embodiments, the cannula has a short cross-sectional axis; andwherein the long cross-sectional axis is at least twice as long as theshort cross-sectional axis.

There is provided, in accordance with some embodiments of the presentdisclosure, a trocar kit for providing intraperitoneal access via a bodyrecess, comprising: an inner dilator, an outer dilator, and a cannula;wherein: the outer dilator is sized and shaped to fittingly insert overthe inner dilator; the cannula is sized and shaped to fittingly insertover the outer dilator; the inner dilator is provided with a roundeddistal tip having a hole sized for the longitudinal pass of a trocarneedle portion having a diameter less than or equal to about 2 mm; andan inner lumen of the cannula has at least one cross-sectional axis ofat least 20 mm; and wherein the inner lumen of the cannula has at leastone cross-sectional axis of less than about 12 mm.

In some embodiments, the inner dilator and the outer dilator are eachtapered from a respective narrower distal insertion end to a respectivefull-size cross-section within 15 mm along a longitudinal axis.

There is provided, in accordance with some embodiments of the presentdisclosure, a method of gaining intraperitoneal access via a bodyrecess, comprising: inserting an inner dilator transvaginally to a wallof a rectouterine pouch; advancing a trocar needle from within the innerdilator to produce an aperture in the wall of the rectouterine pouch;inserting the inner dilator no more than 15 mm into the rectouterinepouch to widen the aperture; inserting an outer dilator no more than 15mm into the rectouterine pouch by sliding the outer dilator over theinner dilator and across the aperture while the aperture is held open bythe inner dilator; and inserting a distal end of a cannula into therectouterine pouch by sliding the cannula over the outer dilator andacross the aperture while the aperture is held open by the outerdilator; wherein an inner lumen of the cannula has at least onecross-sectional axis of at least 20 mm.

In some embodiments, the inner lumen of the cannula has at least onecross-sectional axis of less than about 12 mm.

There is provided, in accordance with some embodiments of the presentdisclosure, a method of gaining intraperitoneal access via a bodyrecess, comprising: inserting a camera to an intraperitoneal space witha wall of a rectouterine pouch in a field of view of the camera;illuminating the wall of the rectouterine pouch using anintraperitoneally positioned illumination device; selecting a positionfor an aperture in the wall of the rectouterine pouch, based on lightfrom the illumination device visible from outside the rectouterinepouch; advancing a trocar needle from outside the rectouterine pouch topress against the selected position in the wall of the rectouterinepouch; verifying the position of the trocar needle, based on one or moreimages from the camera within the intraperitoneal space; and piercingthe rectouterine pouch to from the aperture, using the trocar needle.

There is provided, in accordance with some embodiments of the presentdisclosure, a kit for setting a longitudinal position of a robotic armsystem along a longitudinal axis of a cannula inserted to a bodyorifice, wherein the robotic arm system comprises a motor unit and atleast one robotic arm extending distally from the motor unit along thelongitudinal axis, the kit comprising: a cannula, including a cannulabody configured for insertion to the body orifice and a cannula handleextending proximally along a longitudinal axis of the cannula; amounting block, including a block body and a clamp configured to clampthe cannula handle at a selected longitudinal position relative to theblock body; and a motor unit stopper, including a longitudinallyextended member attached to the block body, and movable between: a firstposition extending a predetermined length from the block body to aproximal end of the motor unit stopper, and a second position; whereinthe proximal end of the motor stopper unit in the first position ispositioned to contact and prevent longitudinal advance of the motor unitupon insertion of the at least one robotic arm to the cannula, therebydefining a predetermined longitudinal position of the robotic arm systemrelative to the cannula; and wherein the second position of the motorunit stopper removes the motor unit stopper proximal end from a positionpreventing the longitudinal advance of the motor unit from thepredetermined longitudinal position.

In some embodiments, the motor unit stopper is attached to the blockbody by a hinge, the first position comprises orientation of the motorunit stopper along the longitudinal axis of the cannula, and movementbetween the first position and the second position comprises rotation ofthe motor unit stopper on the hinge.

In some embodiments, the motor unit stopper is movable between the firstposition and the second position without disturbing the position ofeither the cannula or the motor unit when the at least one robotic armis inserted to the cannula.

In some embodiments, the kit further comprises: the motor unit and theat least one robotic arm extending distally from the motor unit to apredetermined distance from a stopper-receiving portion of the motorunit; wherein a distal end of the at least one robotic arm aligns with adistal end of the cannula when the at least one robotic arm is insertedto the cannula, and the motor unit stopper contacts thestopper-receiving portion of the motor unit to prevent longitudinaladvance of the motor unit.

In some embodiments, the kit comprises a plurality of extenders, eachcomprising a tube with a lumenal cross-section sized to receive arobotic arm having a cross-sectional axis of at least 7 mm, and a lengthsized to extend longitudinally from the proximal end of the stopper to aposition distal to the longitudinal position of the block body.

In some embodiments, the block body is slotted to receive the pluralityof extenders at a position and orientation allowing guidance of roboticarms along the longitudinal axis to an aperture of the cannula body.

There is provided, in accordance with some embodiments of the presentdisclosure, a kit comprising an inner dilator having a distal tip sizedto partially dilate an incision, and an outer dilator sized to slidedistally over the inner dilator to further dilate the incision with adistal tip of the outer dilator, wherein: the overall dilation of theinner and outer dilators is at least enough to allow simultaneousinsertion of at least two cylindrical members each having a diameter ofat least about 8 mm, while a longitudinal distance along each of theinner and outer dilators over which dilation occurs is less than about20 mm; at least one of the inner dilator and the outer dilator aremarked near a proximal end to indicate a relative position at which thetwo dilators are positioned, including at least a mark indicatingalignment of the distal ends of the two dilators, and a mark indicatinga longitudinal position difference of one dilator relative to the otherof the longitudinal distance over which dilation occurs.

In some embodiments, both the inner and outer dilators are marked with adistance scale indicating distance along each dilator to its distal end.

In some embodiments, the distance scales of the inner and outer dilatorsare numerically aligned when the distal ends of each are aligned.

In some embodiments, the kit comprises an indicating indexer configuredto change the force needed to translate the inner and outer dilatorslongitudinally over one another, depending on the relative longitudinalpositions of the inner and outer dilators.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of the present disclosure are described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example, and for purposes ofillustrative discussion. In this regard, the description taken with thedrawings makes apparent to those skilled in the art how embodiments ofthe present disclosure may be practiced.

In the drawings:

FIG. 1 is a schematic representation of portions of a human femalepelvic anatomy, referenced by descriptions herein according to someembodiments of the present disclosure;

FIG. 2A schematically represents a kit of trocar components, accordingto some embodiments of the present disclosure;

FIG. 2B schematically represents distal portions of components in thekit of trocar components, according to some embodiments of the presentdisclosure;

FIGS. 3A-3H schematically represent a method of using trocar componentsto establish intraperitoneal access through rectouterine pouch wall oranother body wall, according to some embodiments of the presentdisclosure;

FIG. 3I schematically represents the cannula configure of FIG. 3H, alongwith inserted tools, according to some embodiments of the presentdisclosure;

FIG. 3J is a schematic flowchart outlining preparation for alaparoscopic procedure using trocar, according to some embodiments ofthe present disclosure;

FIG. 3K is a schematic flowchart representing a method of dilating andcannulating an access incision into a rectouterine pouch, according tosome embodiments of the present disclosure;

FIG. 3L schematically represents a wider view (compared to FIG. 3H) ofthe positioning of cannula relative to anatomical structures of a femalelower abdomen/pelvic region, according to some embodiments of thepresent disclosure;

FIG. 4 schematically represents a dual-verification method of locatingan incision for providing transvaginal access to a rectouterine pouch,according to some embodiments of the present disclosure;

FIGS. 5A-5C schematically represent different stopper mechanisms for usewith trocar components, according to some embodiments of the presentdisclosure;

FIGS. 5D-5F schematically illustrate a needle, needle holder, and needlehandle, according to some embodiments of the present disclosure;

FIGS. 5G-5I schematically illustrate mechanisms for controlling therelative positioning of an inner dilator, outer dilator, and needleaccording to some embodiments of the present disclosure;

FIG. 5J is a flowchart schematically outlining a method of usingindicators to establish and maintain known penetration depths of thetrocar needle, dilator, and/or cannula parts, according to someembodiments of the present disclosure;

FIG. 5K illustrates a manufactured example of a dilation and cannulationkit comprising members described and illustrated in, for example, FIGS.3A-3I and 5D-5I, according to some embodiments of the presentdisclosure;

FIGS. 6A-6E schematically represent dilation using a single dilatortrocar kit, according to some embodiments of the present disclosure;

FIGS. 7A-7B are images taken from inside an insufflated abdomen ofrobotic arms inserted through the cannula in a configuration similar tothat of FIG. 3I, according to some embodiments of the presentdisclosure;

FIGS. 8A-8B illustrate scale features of outer dilator and innerdilator, according to some embodiments of the present disclosure;

FIGS. 9A-9D comprise views representing an instrument holder for cannulaand its configuration for use, wherein instrument holder includes amotor unit stopper for use in setting an initial robotic arm position,according to some embodiments of the present disclosure;

FIGS. 10A-10E schematically illustrate views representing a collapsinginstrument holder for cannula and its configuration for use in settingan initial robotic arm position relative to cannula, according to someembodiments of the present disclosure;

FIGS. 10F-10J schematically represent components of collapsinginstrument holder, according to some embodiments of the presentdisclosure;

FIGS. 11A-11E schematically represent a stepped dilator, dilator handle,and trocar needle, according to some embodiments of the presentdisclosure; and

FIGS. 12A-12C schematically represent a duck-bill gasket used to sealaccess to the proximal aperture of an access device, according to someembodiments of the present disclosure.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates to the fieldof intraperitoneal surgery and more particularly, to devices and methodsfor laparoscopic access to the intraperitoneal space.

Overview

A broad aspect of some embodiments of the present invention relates totrocar components (provided individually and/or in kits) configured toprovide access to intraperitoneal space via the rectouterine pouch forsurgical tools, optionally including one or more surgical robot members(herein, “robotic arms”). Compared, for example, to umbilicus entry tothe intraperitoneal space, rectouterine pouch access to the peritonealspace provides potential advantages for reduced invasiveness, reducedpatient trauma, reduced visible scarring, and/or speed of the operation.

An aspect of some embodiments of the present invention relates to acannula having a lumen with an oblong cross-section, and configured tosimultaneously accept two or more substantially cylindrical toolsextending side-by-side along the lumen.

In some embodiments, a cannula part is provided which has sufficientlongitudinal length to extend between a wall of the rectouterine pouchand a position near to the entrance to the vagina, for example, about7-15 cm long. Optionally, an intravaginal length of cannulation isselectably extended (e.g., between from 7 up to about 15 cm) by use ofthe cannula together with an additional part; for example, a trocarpart, with which it may be telescopically mated. Alternatively, in someembodiments, a selection of different cannula lengths is provided (e.g.,in a length range of from 7 to 15 cm, for example, at least threecannulas in this range; and optionally cannulas of sizes in about 1 cmor 2 cm length increments from each other). This provides a potentialadvantage for avoiding a possibility of pinching between two telescopingcannula portions.

Optionally, the cannula lumen cross-section is sized to providesimultaneous, side-by-side intraperitoneal access to two substantiallycylindrical (e.g., tubular) tools having a diameter of about 8.6 mm. Insome embodiments, the substantially cylindrical tools comprisetube-shaped robotic arms. The cannula lumen cross-section, in someembodiments, has a longest axis at least twice as long as a shortestaxis. Optionally, the cannula cross-section is sized so that there isalso room for a third tool having a cross-section with a maximum axislength of about 6 mm or less. Compared to a circular cross-section sizedto pass two or more such cylindrical tools, such an oblong cross-sectionprovides a potential advantage for allowing a smaller overall cannulaperimeter, with a correspondingly smaller incision needed to accept thecannula.

In some embodiments, the cannula has a distal aperture which is slantedrelative to the longitudinal axis of the cannula so that it opens towardthe direction of intraperitoneal space when inserted into therectouterine pouch. Potentially, this helps to provide space for roboticmembers and/or other tools to bend to enter the intraperitoneal space.

Optionally, the cannula is constructed from stainless steel or anothermaterial which can be sterilized and re-sterilized to surgical usestandards. Optionally, the cannula is disposable and provided in asterilized condition.

An aspect of some embodiments of the present invention relates togeometries of dilators configured to achieve incision dilation whileadvancing to longitudinal distances kept short and/or controlled toavoid trauma to delicate tissues near the rectouterine pouch; and tomethods of dilation adjusted for the geometries of the dilators.

A significant potential complication of opening a rectouterine pouchincision to the intraperitoneal space is damage to the rectum. Thedamage may be due for example, to over-penetration causing puncture,scraping, and/or crushing during initial puncture and/or dilation of theincision. In some embodiments, a constraint on maximum longitudinaladvance is set by the width of the rectouterine pouch, and a need toreduce the potential for accidental damage to nearby internal organs,for example, the rectum.

In some embodiments of the invention, features of a trocar kit and/orits method of use potentially act to reduce a risk of injury due toover-penetration during cannulization. In particular, target insertiondepth (e.g., minimum depth at full dilation) is kept low in someembodiments (e.g., dilation of up to about 7.5-15 mm occurs over about10-20 mm of longitudinal insertion depth, for example, 13 mm, 15 mm, 17mm, 19 mm, or 20 mm). In some embodiments, dilation occurs over about upto 30 mm, 40 mm, or 50 mm of insertion depth.

Overall insertion depth by a dilator after dilation itself is completeis optionally somewhat larger than this (e.g., up to about 2-5.5 cm).However, application of potentially injurious force is particularlylikely during a dilating phase in which the expanding portion of thedilator is being advanced through an incision—since this is the phase ofdilator operation during which overcoming resistance by use ofadditional force is expected and normal.

Optionally, insertion in a dilating phase of operation to an excessivedepth is treated as itself having a higher risk of causing injury (e.g.,due to the internal proximity of delicate tissues) than the elevation ofmaximum peak insertion force that may result from the lowered mechanicaladvantage of a shortened dilation depth.

In some embodiments, dilators are provided as a pair of dilators. Insome embodiments, the pair of dilators comprises a first dilator and asecond dilator, wherein the first dilator is smaller in cross-sectionthan the second dilator. Optionally, the first dilator is provided as an“inner” dilator relative to the second, larger and “outer” dilator. Theinner and outer dilators are configured to slide longitudinally relativeto one another.

In some embodiments, a dilator is provided as a single dilator whichdilates using a stepwise plurality of staged dilator expansions (e.g.,two or three).

In some embodiments, each dilator or dilator step provides expansionfrom an initial incision width (smallest cross-sectional area of thedilator stage) to a final incision width (largest cross-sectional areaof the dilator stage) within about 15 mm of longitudinal advance perstage. Optionally the expansion occurs within another longitudinaldistance of advance, for example, a distance from within the range ofabout 10-20 mm, for example, 13 mm, 15 mm, 17 mm, 19 mm, or 20 mm.

The amount of widening over the travel of the dilator stage isoptionally itself in the range of about 7.5-15 mm, for example, about7.5 mm, 10 mm, 12 mm, 12.5 mm, or 15 mm. This fairly rapid rate ofdilation as a function of longitudinal advance accepts loss ofmechanical advantage in exchange for a reduced required insertion depthto complete dilation. Total insertion depth during dilation can be aboutthe length of a single step (optionally plus a few millimeters past theexpanding part of the dilator, e.g., plus 5-10 millimeters) when aplurality of dilators are used; wherein a subsequent dilator is insertedover the previous dilator. When a single (stepwise expanding) dilator isused, insertion depth during dilation may be the sum of the lengths ofthe individual dilation stages; plus an optional isolating regionbetween the dilation steps having a length of, for example, about 5-15mm; and optionally plus a few more millimeters (e.g., 5-10 mm) past theexpanding part of the dilator. For example, the total insertion depthmay be about 50 mm. In some embodiments, the isolating region is atleast 3 mm long. Additionally or alternatively, the isolating region isless than about 20 mm long.

Related to this, the inventors have realized that mechanical propertiesof the pouch wall tissue related to resisting dilation (e.g., resistanceto tearing and/or stretching) are potentially more permissive of alowered mechanical advantage than the mechanical properties of the wallsof other intraperitoneal access positions, for example, the mechanicalproperties of the skin, fat, and/or muscle layers of the umbilicalregion. This has allowed use of a dilator design which has reducedmechanical advantage (is blunter), in exchange for such potentialadvantages as a shorter dilator insertion depth and/or a smaller numberof dilation steps.

Dividing the dilation into stages (e.g., by using a plurality ofdilators and/or a plurality of isolated dilation steps) potentiallygives greater control over dilation by providing a stopping pointmid-dilation. This potentially reduces a chance of uncontrolled tearingduring dilation, and/or allows inspection of initial dilation to ensurethat there is no unexpected damage (e.g., excessive bleeding) whichmight be aggravated by further dilation.

In some embodiments, the first dilator and/or dilator step has a blunteddistal-most portion. The distal-most portion optionally has a portthrough which a trocar needle can be extended. Optionally, thedistal-most portion curves proximally, widening in both width and heightthrough a radius of at least about 2.5 mm, then expanding primarily inwidth to form a wide oblong cross-section about 15 mm proximal to thedistal-most portion (or another distance, for example in the range ofabout 10-20 mm).

In some embodiments, the second dilator and/or dilator step has adistal-most portion defining a lumen sized to fittingly slide over thefirst dilator. The outer perimeter of the distal-most cross-section isonly slightly larger than the oblong cross-section at the proximal endof the expanding cross-section region of the first dilator. From there,the second dilator's cross-section also expands going proximally forabout 15 mm (or another distance, for example in the range of about10-20 mm). The maximum of the further expansion is by about, forexample, about 5 mm, 7.5, mm, 10 mm, or 12.5 mm. Optionally, there is alarger expansion along one axis of the incision cross-section than alonganother axis; for example, there may be a relative factor of expansionof about 1:1.5, 1:2, or 1:3.

In some embodiments, the cannula is sized to fittingly slide over thesecond dilator to reach a position with its distal aperture insertedwithin the rectouterine pouch.

In some embodiments, the trocar needle used with the first dilator isprovided together with a holder and/or handle which are sized so thatthe maximum distal advance of the trocar needle is limited byinterference between the handle and/or the holder. In some embodiments,the dilators are provided with a stopper and/or indicating indexer whichallow tracking of their relative position, and/or resist, indicate,and/or prevent over-advancement of one dilator relative to the other.

Optionally, the dilator, dilators, handle, holder, and/or trocar needleare constructed from stainless steel or another suitable material whichcan be sterilized and re-sterilized to surgical use standards (e.g., byautoclaving). Optionally, one or more of these parts is disposable andprovided in a sterilized condition.

An aspect of some embodiments of the present invention relates todilator safety performance maintained and/or enhanced by feedbackfeatures and/or methods which help monitor dilator advancement.

In some embodiments, a potential for loss of control of position (e.g.,sudden accidental over-advancement as tissue gives way, and/or as theend of the expanding region of the dilator is reached) is reduced bymoving each dilator with respect to a fixed (e.g., clamped to thepatient table) reference. For example, the first dilator is moved withreference to its initial position and/or an already inserted needle;and/or the second dilator is moved relative to the inserted position ofthe first dilator. Monitoring of position relative to a fixed referenceposition potentially encourages a user of the dilators to ease back onforce when nearing a dilator's target position.

In some embodiments, a stopper arrangement changes (e.g., increases) asliding resistance between two components in relative motion as a targetdilator advancement limit is approached and/or reached. The change mayindicate reaching a target position to a user, and/or mechanicallyresist advance beyond the target position.

An aspect of some embodiments of the present invention relates tomethods of cannulizing a rectouterine pouch wall while monitoring thepenetration using information communicated across the rectouterine wall.In some embodiments, initial rectouterine pouch penetration (e.g., usinga trocar needle) is visualized from using a camera and/or light sourcealready inserted to the intraperitoneal space from another location, forexample, the umbilical. Upon needle contact, a region of indentation maybe interiorly observed before actual puncture. Alternatively oradditionally, transillumination of the rectouterine pouch wall by anintraperitoneally located light source is observed from outside thepouch in order to help position a needle used for initial penetration.The method has a potential advantage insofar as the rectouterine wall islocated both in a difficult region to directly access (due to itsposition deep within the vagina), and nearby sensitive internalstructures which could lead to surgical complications if damaged duringcannulization. Dual inside-to-outside and outside-to-inside needleposition verification allows seeing from the outside (by theillumination) that the targeted port position (aimed at by a needlewhich is to create an initial opening) is in a reasonable locationrelative to internal structures which are to be targeted/avoided, andthen confirming that the actual port position which the needle willcreate really is at the position aimed at.

It is noted that the method described with respect to the rectouterinepouch may be adapted to cannulization of other areas, wherein a firstintroduction of a camera and light source is from a first port into anintrabody space, and cannulization is to be performed to create anotherport in a region which perhaps provides some advantage (e.g., bettersuited to receive a larger incision which is needed for larger tools,and/or provides a preferred direction and/or position of access by thetools), but may also be at greater risk of complication during itscreation (e.g., because it is in a region which is more difficult totarget externally, and/or because it is associated with certain safetyrisks if performed incorrectly). More generally, in some embodiments,where a plurality of ports are to be used, second and subsequent portsmay be opened under two-sided observation after camera and lighting areestablished within a first port.

An aspect of some embodiments of the present invention relates toachieving dependable and preferably rapid initial positioning of roboticarms relative to a cannulated surgical access-way. The cannula helps toprovide access to a region of surgical activity which is not onlyinternal, but also positioned at the end of a restrictive tunnel. Therobotic arms themselves may be articulated along their length in such away that the result of a commanded motion is different depending onexactly what their starting position is relative to the potentialrestrictions on motion presented by the cannula and/or the geometry ofthe internal body space in which they are operated.

Two parameters of particular importance are the distance of longitudinaladvance of one or more robotic arms through the lumen of the cannula,and the angle of approach of the one more robotic arms. An incorrectdistance of longitudinal advance potentially leads to unexpectedlyrestricted motion (e.g., because an articulated arm portion has notadvanced out of the cannula as much as expected), or even injury (e.g.,a collision with body tissue due to over-advancing). An incorrect angleof approach potentially leads to torquing of the robotic arms and/orcannula due to mutual interference as the robotic arms advance. In somemore extreme cases, this could lead to difficulty with robotic armadvance, and/or to disturbance of the cannula position. Even if thealignment is correct enough to achieve safe robotic arm introduction tothe region of surgical activity, robotic arms may not perform fully asexpected, because of lateral interference forces. Such forces arepotentially hard to judge by visual inspection to allow correction orcompensation.

These concerns potentially applies to one or both of robotic armmovements fully under the direct guidance of a surgeon, and robotic armmovements which are at least partially under automatic control.Moreover, it can be difficult to judge the angle of approach and initialdistance of longitudinal advance required for intended device operation,potentially leading to an iterative and/or painstaking setup periodbefore the surgery can begin.

In some embodiments of the present invention, apparatus elementsattached to the cannula are deployed to provide indications of where arobotic arm device should be placed. In some embodiments, these elementsinclude spacing devices and/or guides which, once deployed, provideclear indications of whether robotic arm-cannula alignment is correct,and/or help to prevent incorrect alignments.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings. The invention is capable of otherembodiments or of being practiced or carried out in various ways.

Dilator and Cannula for Rectouterine Pouch Access

Reference is now made to FIG. 1, which is a schematic representation ofportions of a human female pelvic anatomy, referenced by descriptionsherein according to some embodiments of the present disclosure.

Referenced in particular by descriptions herein is rectouterine pouch19, including a portion of rectouterine pouch wall 3 accessible fromvagina 17. Also shown in FIG. 1 are bladder 15, uterus 13, and rectum11. As shown, uterus 13 is in an anteverted position (i.e., tiltedforward toward the bladder). In a significant number of patients, uterus13 may be retroverted (i.e., tilted posteriorly), or in anotherposition. In some embodiments, a retroverted uterus can be manipulatedinto a position which improves intraperitoneal access through therectouterine pouch 3; for example, by use of a uterine manipulator.

Reference is now made to FIG. 2A, which schematically represents a kitof trocar components 200, according to some embodiments of the presentdisclosure.

In some embodiments, the trocar components 200 are sized and shaped toopen an intraperitoneal aperture in the rectouterine pouch 19,transvaginally via vagina 17.

In some embodiments, trocar components 200 comprise a trocar needle 207,an inner dilator 205, an outer dilator 203, and/or a cannula 201, 1010.The components are optionally sized and shaped to be nested one withinthe next in the order listed. Optionally, a distance of longitudinaladvancement of trocar components 200 along one another is indicatedand/or limited by use of a stopper and/or indicating indexer, forexample, leaf spring device 503 or another device, for example asdescribed in relation to FIGS. 5A-5C herein.

Reference is now made to FIG. 2B, which schematically represents distalportions of components in the kit of trocar components 200, according tosome embodiments of the present disclosure. Reference is also made toFIGS. 3A-3H, which schematically represent a method of using trocarcomponents 200 to establish intraperitoneal access through rectouterinepouch wall 3 or another body wall, according to some embodiments of thepresent disclosure.

While FIGS. 3A-3H illustrate a two-dilator expansion procedure, it is tobe understood that more dilators (e.g., three, four, five, or more) areoptionally used. Using more dilators is optionally coupled tosteeper-sloped dilator tip designs (i.e., less expansion per mm ofadvance), which can help to reduce resistance to insertion. Optionally,only one dilator is used (for example as described in relation to FIGS.6A-6E herein). The inventors have found that two dilators, eachexpanding along a longitudinal distance of about 15 mm, are apparentlyenough to reach a fully dilated size of about 30 mm×10 mm, without undueuse of insertion force and/or elevated risk of patient injury. Inparticular, 15 mm appears to be a safe distance of direct penetrationthrough a vaginal wall 3 into rectouterine pouch 19, which does notcarry a significant risk of accidental injury to the adjacent rectum 19.

In FIG. 3A, a distal end of inner dilator 205 is shown advanced to wall3 of rectouterine pouch 19, e.g., with blunt tip 215 positioned incontact with wall 3. The advance is made transvaginally, in someembodiments. Vagina 17 is not shown in the sequence of FIGS. 3A-3H, butmay be understood to surround distal portions of the trocar componentsnear the rectouterine pouch wall 3.

In FIG. 3B, a sharp tip 217 of trocar needle 207 is advanced out of adistal port 216 of inner dilator 205 sufficiently to puncture wall 3 andenter rectouterine pouch 19.

Optionally, trocar needle 207 is no more than 2 mm in diameter (distalport 216 is sized large enough to pass trocar needle 207; for example,distal port 216 may be about 2.1 mm in diameter to pass a trocar needle207 having a 2 mm diameter). Potentially, this limitation on diameterhelps to reduce a risk of serious complications developing in the caseof accidental penetration into rectum 11. Optionally, trocar needle 207comprises a Veress needle having a blunt, spring-loaded center styletwhich in its extended position prevents the sharp tip of the needle frominjuring tissue, but collapses upon sufficient longitudinal force beingexerted so that the sharp tip can operate to penetrate tissue. Such aneedle potentially serves to prevent unintended injury (e.g.,penetration to the rectum 11) during penetration of the wall 3 of therectouterine pouch 19.

In some embodiments, trocar needle 207 is restrained by a stopper devicefrom protruding more than a few millimeters (e.g., no more than about 3mm, 5 mm, 8 mm, or 10 mm) from the distal tip of inner dilator 205 by astopper and/or indicating indexer. Potentially, the restriction onprotrusion reduces opportunity for the needle cause injury byover-penetrating the outer tissue wall to be dilated and injuring aninternal tissue surface. A penetration distance chosen, e.g., 5 mm, maybe enough to stretch and puncture with the trocar needle 207 an outertissue wall having tissue pressed against the inner dilator 205, whilebeing short enough that puncture of any deeper tissue layer beyond theouter tissue wall is prevented. A method of positioning trocar needle207 for penetration is described, for example, in relation to FIG. 4,herein.

In the position of FIG. 3C, inner dilator 205 is advanced through thehole opened by trocar needle 207, up to about the wide cross-section 219of the distal region of inner dilator 205. During the advance, blunt tip215 of inner dilator 205 is first pushed into the hole in wall 3 made byneedle 207. Further advance of dilator 205 widens the hole in wall 3according to the expansion of the tip through tapering region 218 ofdilator 205 between blunt tip 215 and wide cross-section 219. In someembodiments, a first (distal) dilating stage of stepped dilator 1100(that is, a portion of dilator 1100 comprising distal tapering region1121) is used for these operations.

In some embodiments, the overall distance between wide cross-section 219and the distal-most profile of blunt tip 215 (at distal port 216) isabout 15 mm. Potentially, this distance is short enough to preventinjury to the wall of the rectouterine pouch 19 opposite to the wall 3which inner dilator 205 penetrates (e.g., short enough to prevent injuryto the rectum). However, providing some distance of expansion allows thewidening slope of the dilator tip to provide mechanical advantage duringinsertion, so that tissue at the puncture is widened gradually. In someembodiments, another dilator tip length is used, for example about 10mm, 12 mm, 14 mm, 16 mm, or 18 mm.

In some embodiments, blunt tip 215 rounds back from a substantially flatdistal-most profile with a radius of curvature of about 2.5 mm. While ablunt profile potentially results in initially higher resistance to theadvance of inner dilator 205, the blunt tip profile has the potentialadvantage of reducing a likelihood of injury to the wall of therectouterine pouch 19 opposite to the wall 3 which inner dilator 205penetrates (e.g., short enough to prevent injury to the rectum).

Optionally, cross-section 219 is about 20 mm across its longest axis,and about 10 mm across its shortest axis. Optionally, the largest axisof the inner dilator 205 at cross-section 219 is about, for example, 15mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm. Optionally, the shortest axisof cross-section 219 is, for example, about 5 mm, 7 mm, 8 mm, 10 mm, 11mm or 13 mm. Optionally, the ratio between the longest axis and theshortest axis is, for example, about 1.5, 2 2.5, 3, or 3.5. In someembodiments, the expansion of one or both of the longest axis and theshortest axis of cross-section 219 uses the whole available length ofthe dilator tip. In some embodiments, proximal-going expansion acrossthe shortest cross-sectional axis occurs over a distance of, forexample, about 2.5 mm, 3 mm, or 4 mm of longitudinal travel, then levelsout. Optionally, proximal-going expansion across the longestcross-sectional axis occurs over a distance of, for example, about 8 mm,10 mm, 12 mm, 13 mm, 15 mm, or 18 mm.

Optionally, the expansion of the longest cross-sectional axis throughtapering region 218 is substantially linear as a function oflongitudinal distance for a portion of inner dilator 205 leading up towide cross-section 219. Optionally the expansion is non-linear, e.g.,curved to expand faster and/or slower as the overall perimeter of theentry hole into wall 3 grows larger. For example, a relatively blunt tippotentially takes advantage of tissue compliance due to elasticityaround an initially small entrance incision, while a more gradualcross-section expansion is used where non-elastic expansion (e.g., bytearing) dominates.

Optionally, there is a gradual increase in expansion rate (slope) movingstill further proximally. Potentially, this allows percentage stretch ofa hole perimeter as a function of longitudinal advance is maintained ata lower initial value than would be produced by a more linear expansionover the same distance. This may reduce resistance to insertion,potentially reducing a risk of trauma. Optionally, either linear ornon-linear expansion is used through tapering region 213 of outerdilator 203.

In some embodiments, needle 207 is retracted before and/or as innerdilator 205 is advanced, potentially reducing a risk of injury to theopposite wall. In some embodiments, the distance of advance of innerdilator 205 is controlled by recording the position of inner dilator 205upon needle penetration, and comparing that position to more advancedpositions. Optionally, a stopper is positioned after initial penetrationby needle 207 and locked into place relative to the patient (e.g.,locked to the table by a positioning arm) so that no more than apredetermined total advance distance (e.g., 15 mm) is allowed.

In FIG. 3D, outer dilator 203 is shown longitudinally advanced overinner dilator 205 until it reaches wall 3 of rectouterine pouch 19(e.g., so that distal edge 212 of outer dilator 203 contacts wall 3). InFIG. 3E, outer dilator 203 is advanced further, up to the level of thewide profile 214 of outer dilator 203. It is noted that the advance inFIG. 3E shows the distal edge 212 of outer dilator 203 brought to thesame longitudinal position as the distal-most profile of inner dilator205. In some embodiments, a second (proximal) dilating stage of steppeddilator 1100 (that is, a portion of dilator 1100 of FIGS. 11A-11Ecomprising proximal tapering region 1117) is used for these operations;except that instead of advancing over an inner dilator, the proximaltapering region 1117 follows after distal tapering region 1121, andoptionally after an intervening isolating region 1119, as describedherein in relation to FIGS. 11A-11E.

FIGS. 3A-3D show first insertion of inner dilator 205, then outerdilator 203 over inner dilator 205. In some embodiments, outer dilator203 is optionally used as the first inserted dilator (or insertion alongwith inner dilator 205), followed by puncture using trocar needle 203,dilation with the inner dilator 205 sliding distally from within outerdilator 203, and finally dilation with outer dilator 203 slidingdistally over inner dilator 205. This provides a potential advantage,for example, in the location of a puncture target location for needle207, which can be seen through the relatively open lumen of outerdilator 203 upon transillumination of the wall 3 of the rectouterinepouch 19. The difference in insertion order can also affect thearrangement of stoppers/indicating indexers (for example as described inrelation to FIGS. 5A-5I) used to determine the relative distances of thedifferent dilation components during insertion and/or dilation.

Optionally, the distal aperture 220 of outer dilator 203 is sized tofittingly accommodate the wide cross-section 219 of inner dilator 205.The outer perimeter at distal edge 212 may be just slightly larger thandistal aperture 220 (i.e., distal edge 212 is optionally sharp).Optionally, distal edge 212 is blunt and/or rounded, for example, withan initial wall thickness (or diameter, in the case of a rounded edge)of, for example, about 100 μm, 200 μm, 500 μm, or 1 mm.

In some embodiments, the distance between distal edge 212 and wideprofile 214 is about 15 mm. In particular, the distance is optionallyany distance described in relation to the distance between thedistal-most profile of inner dilator 205 and wide cross-section 219.Optionally, these two distances are about equal. Optionally, thedistance for outer dilator 203 is slightly shorter (e.g., about 0.5 mm,1 mm, or 1.5 mm shorter), which potentially reduces a possibility ofinjury due to tissue contact with distal edge 212. Optionally, adistance of advance of outer dilator 203 relative to inner dilator 205is controlled by use of a stopper and/or indicating indexer, for exampleas described in relation to FIGS. 5A-5C herein.

Optionally, the longest axis of wide cross-section 214 is, for example,about 20 mm, 23 mm, 25 mm, 27 mm, 33 mm, or 35 mm. Optionally, theshortest axis of wide cross-section 214 is, for example, about 5 mm, 7mm, 8 mm, 10 mm, 11 mm, or 13 mm. Optionally, the ratio between thelongest axis and the shortest axis is, for example, about 1.5, 2 2.5, 3,or 3.5. The dimensional descriptions apply as well to slanted distalaperture 209 of cannula 201, 1010 and the internal lumen of cannula 201,1010 which is sized to slide over outer dilator 203 in a fittingassociation (e.g., with a relative size tolerance of about 1 mm orless). The internal lumen of cannula 201, 1010 is sized to accept aplurality of (typically tubular, tube-sheathed and/or cylindrical) toolspositioned side-by side, for example, two tools of 8 mm diameter or moreand one tool of about 5-6 mm diameter or more. In some embodiments, thecross-sections of the cannula 201, 1010 and dilators 203, 205 are (forexample as shown in FIGS. 2B and 5K) substantially rectangular withrounded ends (e.g., rounded so that the short sides are formed assections of substantially circular arcs).

A rounded-end shape has a potential advantage for enclosing a pluralityof side-by-side cylindrical tools, since it allows packing of theoutermost tool sides toward the outside of the cross-section, whileminimizing wasted corner space (the “waste” is not so much with respectto the cannula interior as it is with respect to the creation of apotentially larger-than-necessary incision hole). Round corners (asopposed to sharp corners) also provide a potential advantage duringinsertion, by helping to distribute forces which might otherwise tend tofocus cutting toward the corners and lead, e.g. to less predictabledilation and/or incisions which heal more unpredictably. Between thearced ends, a straight line section (used in some embodiments) has thepotential advantage of maintaining an outer profile suitable for stayingin full peripheral contact with the dilated tissue surrounding it (e.g.,to maintain a tension seal), without extra widening which would createspace that the cylindrical tools within do not need to use. In someembodiments, there is a slight outward bowing introduced along thelonger sides of the cross-sections (e.g., less than 1 mm of bowing per 5mm of perimeter), potentially enhancing tension contacts between thedilators and/or cannula and the aperture edges of the tissue wall theypenetrate.

In the examples illustrated herein (e.g., FIGS. 2B, 5K), thecross-sections of the dilators and cannula shown display mirror symmetryaround both a long axis and a short axis. However, the cross-sectionalshape, in some embodiments, need not have any particular symmetryarrangement, and can be otherwise shaped (e.g., as a round-corneredirregular triangle) to suit the accommodation of different-sizedarrangements of tools.

In FIG. 3F, vaginal cannula 201 is shown with its distal-most edge 211brought up to the position of wall 3. In FIG. 3G, cannula 201 is shownadvanced into the rectouterine pouch 19, so that distal-most edge 211 isabout even with the distal-most portion of outer dilator 203. FIG. 3Hshows cannula 201 with inner dilator 203 and outer dilator 205 removed.Optionally, inner dilator 205 is removed at any time after outer dilator203 is in place. Optionally, the two dilators 203, 205 are removedtogether.

In some embodiments, an inner lumen cross-section of cannula 201 issized to fittingly slide over section of outer dilator 203 having thesize of wide cross-section 214. Optionally advance of cannula 201 isperformed by use of a handle 202. Optionally, the maximum advance ofcannula 201 relative to outer dilator 203 is controlled by the use of astopper and/or indicating indexer.

In some embodiments, the lumen of cannula 201 is about 7 cm, or anotherlength long enough to reach between a distal-most position within therectouterine pouch, and a proximal position at or outside the vaginalorifice (e.g., up to about 15 cm). Optionally, a flange 221 is providedat a proximal end of the lumen of cannula 201. While cannula 201 (with ahandle 202, as next described) is shown in FIG. 3F-3I, it should beunderstood that the foregoing descriptions of cannula 201 also apply, insome embodiments, to the use of cannula 1010 of FIG. 10B.

Handle 202 of cannula 201 is long enough, in some embodiments, to extendpast either of the dilators 203, 205 while they are inserted, and enoughpast to provide a grasping region (e.g., a grasping region of about 10cm; overall length is optionally at least about 37 cm). In someembodiments, inner dilator 205 is at least long enough to reach itsfully inserted position while providing a handle (e.g., about 17 cmoverall), and outer dilator 203 is at least 10 cm longer again (e.g.,about 27 cm overall).

Reference is now made to FIG. 3L, which schematically represents a widerview (compared to FIG. 3H) of the positioning of cannula 201, 1010relative to anatomical structures of a female lower abdomen/pelvicregion, according to some embodiments of the present disclosure. Amongthe anatomical structures shown are the uterus 15, vagina 17, bladder15, rectum 11, and rectouterine pouch 19, also shown as in FIG. 1. Notshown is the handle of cannula 201, 1010, and optional associateddevices such as insufflation sealing which may be provided for, e.g., atthe vaginal orifice, and/or a trocar part which may be telescopicallyfitted to extend the length of cannula 201, 1010.

In some embodiments, slanted distal aperture 209 of cannula 201, 1010 isslanted at an angle between a leading distal-most edge portion 211, anda following, more proximal edge portion 210. The longitudinal distancebetween distal-most edge portion 211 and proximal-most edge portion 210,in some embodiments, is about 15 mm. In some embodiments, the distanceis, for example, about 10 mm, 12 mm, 14 mm, 16 mm, or 18 mm. A potentialadvantage of the slanting of distal aperture 209 is to allow the cannulaedge to be relatively retracted on an unprotected side of the cannulawhich could otherwise be accidentally positioned to scrape the rectum11. As for the more-protruding leading-edge side of the aperture 211:(1) upon insufflation, tissue is generally lifted away from the rectum,reducing contact risk posed by this side, and (2) the robotic arms,where they exit the cannula, will generally be curved across the planeof the leading edge as they reach deeper into the peritoneal space. Thispotentially prevents contact of the leading edge with delicate internaltissues. Robotic arm positions can be seen, for example, in FIGS. 7A-7B,herein.

Reference is now made to FIG. 3I, which schematically represents thecannula configuration of FIG. 3H, along with inserted tools, accordingto some embodiments of the present disclosure. Reference is also made toFIGS. 7A-7B, which are images (from a viewpoint inside an insufflatedabdomen) of robotic arms inserted through the cannula 201 in aconfiguration similar to that of FIG. 3I, according to some embodimentsof the present disclosure. Descriptions in relation to FIGS. 3I and7A-7B of cannula 201 also apply to cannula 1010 of FIG. 10B.

In FIG. 3I, the lumen of cannula 201 is shown occupied by twosubstantially cylindrical members, for example, robotic arms 305 (havingdiameter, for example, of about 8.6 mm), and another cylindrical (e.g.,tubular) member comprising a tool 307 (for example, a laparoscopicilluminator, camera, clamp, cutter, and/or another tool). In someembodiments, the lumenal cross section of cannula 201 is sized toaccommodate a plurality of substantially cylindrical members (e.g.,robotic arms) each having a diameter of at least about 8 mm, andoptionally another tool operated through a tube having a diameter of atleast about 5 mm.

As shown in FIG. 3I, tools exiting the slanted distal aperture 209 ofcannula 201 positioned within rectouterine pouch 19 are optionallyoriented to curve downward from the aperture, into the rest of theperitoneal space where operations of a laparoscopic procedure are to beperformed (for example, clipping ligaments in preparation forhysterectomy. Optionally, this orientation is assisted by the angledslot of distal aperture 209 described in relation to FIGS. 3F-3H,herein.

In FIGS. 7A-7B, robotic arms 305 include surgical tools 704 positionedon a distal end of each robotic arm 305. The robotic arms 305 are shownentering into an insufflated abdominal cavity from cannula 201 throughslanted distal aperture 209. Also illustrated in the image is thedilated incision 702 through which cannula 201 has entered the abdominalcavity.

Reference is now made to FIG. 3J, which is a schematic flowchartoutlining preparation for a laparoscopic procedure using trocar 200,according to some embodiments of the present disclosure. The procedureshown represents a setup portion of a larger procedure (for example, ahysterectomy), including elements of the method described in relation toFIGS. 3A-3I.

Optionally, at block 110, in some embodiments, a laparoscopicallymounted camera is inserted into the peritoneal space, for example fromthe umbilical. Optionally, the camera is provided together with anillumination source. Optionally, a separately mounted illuminationsource is also inserted from the umbilical.

At block 112, in some embodiments, the peritoneal space is insufflated,e.g., by inflating with CO₂. Insufflation is performed to enhance accessand/or visibility during the procedure.

At block 114, in some embodiments, a sleeve is inserted transvaginally.The sleeve potentially helps to maintain insufflation pressure(pseudo-peritoneum) used for visualization and/or access during the restof the procedure. The sleeve may be provided, for example, as an Alexis®nylon sleeve (Applied Medical Resources Corporation), or as part of aGelPOINT® path transanal access platform (Applied Medical ResourceCorporation). In some embodiments, the sleeve is inserted at a laterstage; for example just before attachment of a sealing unit at block122.

At block 116, in some embodiments, a speculum is inserted to the vaginato assist in visualization (optionally or additionally, a tenaculum isused).

At block 118, in some embodiments, a uterine manipulator is insertedtransvaginally to the uterus. The uterine manipulator may be, forexample, a Karl Storz uterine manipulator. The uterine manipulator isused to move the uterus during the procedure, for example, to helpprovide maneuvering room for other instruments, and/or to help move theuterus away from the rectum to provide increased safety. If a tenaculumwas used, the tenaculum may be removed at this point.

At block 120, in some embodiments, dilation and cannula introduction isperformed, for example, as described in relation to FIGS. 3A-3G, FIG.3K, FIGS. 6A-6E, and/or FIGS. 11A-11E herein. The speculum may beremoved during dilation, for example if it begins to interfere withdilation, or afterward.

At block 122, in some embodiments, a sealing unit is attached to cannula201 (or cannula 1010, for example as described in relation to FIGS.10A-10C, herein). The sealing unit optionally comprises elements of aGelPOINT® system; optionally in combination with elements specificallyadapted for use with cannula 201. Optionally, the uterine manipulator isre-positioned to pass through the sealing unit.

At block 124 in some embodiments, fixation is performed. Fixationcomprises securing of the cannula and/or sealing unit to a platformwhich is stationary relative to the patient (e.g., an operating table).

At block 125, in some embodiments, one or more robotic arms are alignedto cannula 201, 1010 in preparation for introduction into cannula 201,1010, for example as described in relation to FIGS. 9A-9D or FIGS.10C-10J, herein.

At block 126, in some embodiments, one or more robotic arms and/or othertools are introduced through the cannula 201, 1010, for example asdescribed in relation to FIG. 3H herein.

Reference is now made to FIG. 3K, which is a schematic flowchartrepresenting a method of dilating and cannulating an access incisioninto a rectouterine pouch, according to some embodiments of the presentdisclosure. In some embodiments, the method of FIG. 3K detailsoperations of block 120 of FIG. 3J.

The method is outlined briefly. Additional details for the operations ofFIG. 3K are described in relation to FIGS. 3A-3G, herein.

At block 130, in some embodiments, inner dilator 205 (alternatively, insome embodiments, stepped dilator 1100 of FIGS. 11A-11E) is insertedtransvaginally to reach a wall 3 of the rectouterine pouch 19 (forexample as described in relation to FIG. 3A). At block 132, in someembodiments, a tip of a needle (inserted through inner dilator 207) islocated at the site where an access incision is to be made (for example,as detailed in relation to FIG. 4). At block 134, in some embodiments,the rectouterine pouch is punctured (for example, as described inrelation to FIG. 3B). At block 136, in some embodiments, the pouch wall3 is crossed with the first dilator stage, for example, a tip of innerdilator 205 (for example as described in relation to FIG. 3C).Alternatively, in some embodiments, pouch wall 3 is crossed with a first(distal) dilating stage of stepped dilator 1100. At block 138, in someembodiments, the pouch wall 3 is crossed with a second dilator stage,for example, the outer dilator 203 (for example, as described inrelation to FIGS. 3D-3E). Alternatively, in some embodiments, pouch wall3 is crossed with a second (proximal) dilating stage of stepped dilator1100. At block 140, in some embodiments, the pouch wall is crossed withcannula 201, 1010 (for example, as described in relation to FIGS.3F-3G). At block 142, in some embodiments, the dilators 203, 205 and/ortrocar needle 207 are removed, and the flowchart ends.

Reference is now made to FIG. 4, which schematically represents adual-verification method of locating an incision for providingtransvaginal access to a rectouterine pouch 19, according to someembodiments of the present disclosure.

Shown in FIG. 4 is a schematic representation of rectouterine pouch 19,including a vaginal wall 3 of the rectouterine pouch 19, approached byan inner dilator 205, with a trocar needle 207 partially extended. Alsoshown are an intraperitoneally inserted (e.g., from the umbilical)camera 402 and an illumination source 401. Camera 402 and illuminationsource 401 are shown on the same laparoscopic instrument 400; optionallythey are separately provided. Camera 402 has an associated field of view402A, while illumination source 401 has an associated illumination field401A.

In some embodiments, the tip of needle 207 is positioned before punctureagainst a region of wall 3, wherein the region selected based onexternal observation of light from illuminator 401 visible from outside(e.g., as viewed transvaginally, optionally using the speculum and/oruterine manipulator to increase visibility). Optionally, the regionselected is a region through which trans-illumination light intensity isobserved to be relatively large compared to surrounding regions. Suchwell trans-illuminated wall areas are potentially among the thinnest,most easily penetrated portions of wall 3 accessible to needle 207.

In some embodiments, as needle 207 is pressed against wall 3 to punctureit, camera 402 is used to visualize the results. In the camera images,for example, there may be initially a protrusion, other tissuedistortion, and/or other change (e.g., a color change due to pressure onthe tissue) visible at the site of penetration (e.g., a distortionvisible from a side of wall 3 opposite a side contacting the needle),and afterwards the needle itself may become visible. Optionally, thevisualization helps to verify that the intended region is beingpenetrated (e.g., that the region being penetrated is suitable toprovide intraperitoneal access), and/or to help identify and/or preventimminent rectal puncture or another insertion mistake. By using visualcues that communicate across the rectouterine wall 3, even before thewall 3 itself has been punctured, complications may potentially beavoided.

Reference is now made to FIGS. 5A-5C, which schematically representdifferent stopper and/or movement interference devices for use withtrocar components 200, according to some embodiments of the presentdisclosure.

FIG. 5A illustrates a stopper-and-shoulder type of stopper device. Inthis embodiment, outer dilator 203 is inserted first, or along withinner dilator 205. The view of FIG. 5A cuts away a portion of outerdilator 203 so that the connection between inner dilator 205 andproximal stopper 501 can be seen.

Proximal stopper 501 is positioned along inner dilator 205 at a positionwhere surface 501A is brought into abutment with a proximal surface(cut-away in FIG. 5A) of outer dilator 203 at the position where innerdilator 203 is as far distal relative to outer dilator 205 as it shouldbe allowed to go (e.g., with a distal-most portion of inner dilator 205positioned 15 mm in advance of a distal-most portion of outer dilator203). Then, when it is the turn of outer dilator 203 to be advanced, thedistance between surface 501A and the proximal surface of outer dilator203 can be measured to determine the advance distance. Optionallyanother stopper device (for example, that of Figure SB and/or SC)prevents and/or indicates distal over-advancement of outer dilator 203relative to inner dilator 205.

FIG. 5B illustrates a leaf-spring based stopper and/or motioninterference device. The device comprises a bracket 504 attached to adistal portion of outer dilator 203, which in turn supports a leafspring 505 configured to press down onto the body of inner dilator 205.This interaction optionally is set to a force sufficient to retard freesliding (e.g., due to gravity) of the inner dilator 205 relative to theouter dilator 203.

Optionally, inner dilator 205 comprises a receiving shape 505A (hiddenby leaf spring 505) which is positioned to contact leaf spring 505 andinterfere with further longitudinal movement of outer dilator 203relative to inner dilator 205. The stopper device may be used to preventover-advancement of either or both of inner dilator 205 and outerdilator 203 with respect to one another. There may be a plurality ofdifferent receiving shapes 505A, allowing different positioned to benoted. Though referred to as a “stopper”, the stopper device of FigureSB is optionally configured using shapes and/or surface friction thatinterfere to resist, rather than completely prevent further longitudinalmotion. The stopper device of Figure SB in such embodiments may bealternatively described as an indicating indexer. Optionally, theindicating indexer indicates relative dilator positions by the positionsfrom which further longitudinal movement is resisted, and/or positionsat which the two dilators click into place (as indicated through audibleand/or tactile feedback).

The interfering occurs at one or more relative longitudinal positions ofthe two dilators 203, 205, for example, when the two are positioned withtheir distal-most portions in alignment, as shown in FIG. 3E. Receivingshape 505A may comprise, for example, an inset portion into which leafspring 505 falls when the two parts are aligned. Additionally oralternatively, receiving shape 505A comprises a raised portion. In thiscase, a lumen of outer dilator 203 may be shaped to pass over the raisedportion of receiving shape 505A until leaf spring 505 encounters it.Alternatively, lumen of outer dilator 203 may be shaped to preventpassage of the receiving shape, so that it also acts as a type ofstopper-and-shoulder arrangement. It should be understood that althoughthe device is illustrated with respect to two nested dilators, it mayalternatively or additionally be implemented between a cannula and adilator.

FIG. 5C represents a different leaf-spring based stopper device. In thisexample, there are optionally provided be a plurality of leaf springs503 mounted to the body of outer dilator 203. Somewhere along itslength, inner dilator 205 has a receiving shape (not shown), whichcomprise an indentation and/or a raised portion that contacts leafspring 503 at a certain relative longitudinal position of the twodilators 203, 205; for example, when the two are positioned with theirdistal-most portions in alignment, as shown in FIG. 3E. The leaf springdevice of FIG. 5C can be placed in any suitable location along the bodyof outer dilator 203, but preferably in a location that remains outsidebody cavities during use. There may be a plurality of such devicesprovided on outer dilator 203, and/or a plurality of receiving shapesprovided on inner dilator 205. Optionally, the leaf spring device isprovided on inner dilator 205, and the outer dilator provided with theappropriate receiving shape(s).

In some embodiments, a stopper and/or motion interference devicereplaces the leaf spring with another mechanism. For example, in someembodiments, a plunger is provided (e.g., a spring-loaded pressingmember such as a ball bearing, for example as described in relation toFIGS. 8A-8B). The plunger presses down to hold two nested parts inrelative position (e.g., two dilators; dilator and cannula), and/orindicate that a particular relative position has been reached, by forceof friction and/or by interference between the plunger and one or morestopper/indicating indexing shapes—and/or by release of suchinterference and/or friction.

Reference is now made to FIGS. 5D-5F, which schematically illustrate aneedle 207, needle-passing dilator handle 510, and needle handle 511,according to some embodiments of the present disclosure.

In FIG. 5D, needle 207 is shown partially inserted within the hollowbody of dilator handle 510. Optionally, dilator handle 510 serves as ahandle for inner dilator 205; e.g., attached via a screw thread or otherattachment means. Proximal end 512 of needle 207 is adapted to attach toneedle handle 511 of FIG. 5E, for example as shown in FIG. 5F. In someembodiments, the relative lengths of needle 207 and dilator handle 510(and the relative position of handle 511 on needle 207) are configuredto help control the maximum distance of distal advance of needle 207relative to inner dilator 205, for example as described in relation toFIGS. 5G-5I.

Reference is now made to FIGS. 5G-5I, which schematically illustratedevices for controlling the relative positioning of inner dilator 205,outer dilator 205, and needle 207 according to some embodiments of thepresent disclosure. Reference is also made to FIGS. 8A-8B, whichillustrate scale features of outer dilator 203 and inner dilator 205,according to some embodiments of the present disclosure.

In FIG. 5G and FIGS. 8A-8B, outer dilator 203 is shown provided with anintegrated scale window 515. Scale window 515 optionally comprises atleast one reference mark alongside a longitudinal window formed in aportion (e.g., cut into a proximal end) of outer dilator 203. In someembodiments, outer dilator 203 is used to define a reference positionallowing inference of the current position of the wall 3 of rectouterinepouch 19. Outer dilator can be inserted as far as it will easily pass.Since it is too blunt to puncture wall 3, it will normally be brought toa halt with its distal-most end abutting wall 3. This can be verified byviewing using a speculum, for example.

In some embodiments, a distance scale is marked (e.g., in centimetersfrom the distal end) on one or both of the inner dilator 205 and outerdilator 203, for example, scale 811 of the outer dilator 203, and scale813 of the inner dilator 205 (FIGS. 8A-8B).

Also illustrated in FIGS. 8A-8B is ball-stop device 815, which is anexample of an indicating indexer. In some embodiments, ball stop device815 comprises a spring-loaded ball bearing, configured to protrudeoutwards from near a proximal end of inner dilator 205 under elasticpressure. The lumen of outer dilator 203 is sized so that it can bepushed over and then slide forward along ball-stop device 815. The ballof ball-stop device 815 is pushed inward during this motion. It acts (bycontinuing to press outward) to help center outer dilator 203 over innerdilator 205, and optionally to resist spontaneous relative translation(sliding) of the two dilators (e.g., due to the weight of outer dilator205). Upon sufficient advance of outer dilator 203, ball-stop device 815is freed from the proximal side of outer dilator 203, potentiallyinducing a tactile and/or audible click, and/or causing changes to themechanical handling of the dilators 203, 205 which indicate to a userthat outer dilator 203 has been fully advanced. Optionally, outerdilator 203 comprises one or more indentations and/or bumps along itslumen at positions which change the force with which the ball-stopdevice 815 interferes with relative longitudinal translation of thedilators 203, 205. It should be understood that the ball-stop device 815may alternately be provided on the outer dilator 203 at a position whereit interacts while sliding with the inner dilator 205 (and optionallybumps and/or indentations thereof). An indicating indexer is optionallyprovided for indication and/or control of relative longitudinalpositions of other pairs of elements of the trocar kit; for example,between inner dilator 205 and needle 207, and/or between outer dilator203 and cannula 201, 1010. In some embodiments, a ball stop is providedwhich controls relative motion between stepped dilator 1100 and cannula201, 1010 when locked. In some embodiments, a ball stop is providedwhich controls relative motion between cannula 1010 and an access device1001 (FIG. 10A) when locked.

In FIG. 8B, the ball stop device 815 is shown still compressed by outerdilator 203. In FIG. 8A, the ball stop device is free of compression.Once the ball-stop device 815 is free of compression, the ball ispressed outward to the full extent of its travel, resulting in anincreased resistance (upon contacting a proximal surface 817 of outerdilator 203) to accidentally pushing inner dilator 205 distally relativeto dilator 203.

In FIG. 5H, inner dilator 205 is shown partially inserted into outerdilator 203. Scale markings 517 on inner dilator 205 allow monitoring ofthe distal advance of inner dilator 205 relative to outer dilator 203,e.g., to a position distally even with the distal end of outer dilator203 (in preparation for needle puncture), and/or to a position a fewmillimeters (e.g., 15 mm) distally in advance of outer dilator 205during initial dilation.

Also in FIG. 5H, needle 207 is shown still only partially advanced withrespect to handle 510 and the dilators 203, 205. In some embodiments,dilator handle 510 fits (e.g., screws into) to a socket in inner dilator205, holding it at a predetermined distance from the distal end of innerdilator 205.

In FIG. 5I, the relative positions of components shown is as may occurimmediately after needle 207 punctures the wall 3 of the rectouterinepouch 19.

The distal-most end of inner dilator 205 has been brought forward evenwith the distal-most end of outer dilator 203, as monitored from therelative positions of scale window 515 and markings 517. Handle 511 hasbeen pushed forward so that it abuts a proximal end of dilator handle510, preventing further advancement of needle 207. Lengths of needle207, inner dilator 203, and dilator handle 510 are set so that needle207 now protrudes from the front of inner dilator 203 by a predeterminedamount which has been determined to fall within the range of distanceswhich are enough to penetrate a wall 3 of a rectouterine pouch 19, butavoid risk of also penetration a wall of the rectum 11.

Optionally, the distal-most end of inner dilator 205 remainslongitudinally offset from (e.g, distal to) the distal-most end of outerdilator 203 by some distance to control the maximum advance of needle207. Optionally, maximum advance of needle 207 relative to inner dilator205 is performed first, before advance to penetrate wall 3. Thisprovides a potential advantage for allowing marked relative positions ofwindow 515 and scale 517 to indicate the distance of needle advance indetail.

During dilation, in some embodiments, distal advance of outer dilator203 relative to inner dilator 205 potentially disrupts the longitudinalframe of reference that outer dilator 203 initially establishes. In someembodiments, the frame of reference is maintained by clamping innerdilator 205 into place once it has advanced into the rectouterine pouch.

Reference is now made to FIG. 5K, which illustrates a manufacturedexample of a dilation and cannulation kit comprising members describedand illustrated in, for example, FIGS. 3A-3I and 5D-5I, according tosome embodiments of the present disclosure. Items are to scale with eachother, and shown along their total length, with the exception of needle207, which has been truncated on the right hand (sharpened, distal)side. Illustrated, from top to bottom, are:

-   -   Needle 207 including handle 511,    -   Cannula 201, including handle 202 and slanted distal aperture        209, comprising proximal edge portion 210 and distal-most edge        portion 211.    -   Outer dilator 203, including scale window 515, distal edge 212,        tapering region 213, and the wide profile 214 at the proximal        side of tapering region 213.    -   Inner dilator 205, including distal port 216 positioned in blunt        tip 215, tapering region 218, and the wide cross-section 219 at        the proximal side of tapering region 218.    -   Dilator handle 510, which may optionally be attached to (e.g.,        screwingly attached to) inner dilator 205 to serve as a        proximal-side handle thereof.

Reference is now made to FIGS. 6A-6E, which schematically representdilation using a single dilator trocar kit, according to someembodiments of the present disclosure.

FIG. 6A shows a schematic representation of a body cavity (e.g., avagina 17), together with an access device 601 which is optionally used,e.g., to help maintain insufflation pressure. In FIG. 6B, a uterinemanipulator 603 is optionally added (shown incompletely inserted),potentially allowing maneuvering to increase visibility of the trocartarget region (which may be a wall 3 of a rectouterine pouch 19, notshown). In FIG. 6C, cannula 605 (optionally constructed as describedherein in relation to cannula 201 or cannula 1010) is inserted to thetarget region. Cannula 605 comprises a handle 605A to allow maneuveringof the lumen region of the cannula 605.

In FIG. 6D, a dilator 607 is being inserted to cannula 605, optionallyusing handle 607A. The tip of dilator 607 is optionally shaped to beginat its distal-most longitudinal position with a cutting tip.Alternatively, the tip of dilator 607 is blunted (shaped, for example,like that of inner dilator 205). Optionally, dilator 607 allows forpassage distally of a trocar needle via an aperture. Optionally, initialpuncture is made separately by a needle, e.g., passed into the lumen ofcannula 605 (not shown), and dilator 607 inserted afterward.

In some embodiments, the tip of dilator 607 expands to any appropriatecross-sectional size; for example, any cross-section described inrelation to wide cross-section 219. Optionally, the longitudinaldistance between distal-most position and the tip cross-section ofgreatest expansion is about 15 mm or any other suitable distance; forexample, as descried in relation to dilator tips of dilators 203, 205.Relative to use of two or more dilators, one-step dilation over the samemaximum dilator tip distance is potentially simpler from the point ofview of component exchanges and manipulations. There is a potentialtradeoff, however, of increased penetration length (e.g., if expansionangle is maintained), and/or (e.g., if expansion angle is increased) ofincreased resistance to penetration.

In FIG. 6E, the tip of dilator 607 is shown maximally advanced, withdilation complete. To complete trocarization, the cannula 605 may now beadvanced through the dilated aperture, and the dilator 607 removed.

Reference is now made to FIG. 5J, which is a flowchart schematicallyoutlining a method of using indicators to transitively establish andmaintain known insertion depths of the trocar needle 207, dilator 203,205, and/or cannula 201, 1010 parts, according to some embodiments ofthe present disclosure.

At block 551, in some embodiments, a first dilator (e.g., inner dilator205) is brought into position with its blunt tip against the outer wallof the rectouterine pouch. This position may be established, forexample, by direct visualization (e.g., using a speculum), by notingwhere insertion resistance is encountered, and/or indirectly, e.g., byshining a light through the dilator lumen, and monitoring the projectedlight spot (e.g., the position where the spot reaches its smallest, mostsharply defined shape) through the rectouterine pouch wall using acamera positioned inside the intraperitoneal space. Optionally, thefirst dilator is held clamped in position, e.g., by a table-attachedclamping arm. Optionally, at block 552, the depth of penetrationrelative to the natural orifice opening is noted, providing a totalvaginal length (TVL) which may be used separately from the transitivemethod of establishing trocar component positions, and/or to verifyinsertion depths set by the transitive method.

At block 553, in some embodiments, a trocar needle 207 is inserted intodilator 205, e.g., via holder 210. Insofar as holder 210 is itself sizedto insert to a predetermined longitudinal position relative to the firstdilator, the amount of visible shaft of trocar needle 207 optionallyprovides an indication of where the needle tip is positioned relative tothe distal end of the first dilator. This can be used to control anadvancing distance of trocar needle 207, optionally along with a stopperdevice (such as a shoulder stopper) that prevents over-advancement ofthe trocar needle 207. Optionally, the needle remains in place at leastuntil the first dilator is advanced over it.

At block 555, in some embodiments, a second dilator (e.g., outer dilator203) is advanced over the first dilator until a part of the seconddilator (e.g., its proximal end, or an index mark) it is suitablyaligned to a part of the second dilator (e.g., an index marking on ascale). If an index scale is used, it may be on either or both of thefirst and second dilator. For the sake of description of the method, thedistal ends of the first and second dilators are assumed to be alignedto one another in the aligned position; optionally, they are offset bysome known amount. Additionally or alternatively, the insertion depth ofthe second dilator relative to the total vaginal length is used tolongitudinally position and/or verify the position of the seconddilator.

At this stage, the longitudinal positions of the distal ends of thefirst dilator and second dilator are both known relative to that of therectouterine pouch wall which is to be dilated. Optionally, eitherdilator can be advanced or retracted relative to the other in anysuitable sequence, and so long as the sequence of movements and theirdistances are tracked, their positions relative to the rectouterinepouch wall will remain known.

For example, at block 557, in some embodiments, the first dilator isadvanced into the rectouterine pouch while the second dilator remainsfixed (e.g., clamped). The relative motion is optionally monitored bylooking at scale marking motions on the proximal ends of the dilators.At block 559, e.g., once the first dilator is sufficiently advanced (forexample, 15 mm) to achieve a full first-stage dilation, the seconddilator is advanced (e.g., until the original relative alignment of thetwo is restored). Additionally or alternatively, the changing insertiondepths are controlled/monitored relative to the total vaginal length.

Additionally or alternatively (at blocks 558 and/or 560), advancingdistance is controlled by making reference to the TVL determined atblock 552.

From this position, at block 561, the first dilator (and trocar needle207, if not yet withdrawn) may be removed; and the second dilator mayremain as a longitudinal positioning reference for positioning thecannula 201 at block 563. Optionally, the cannula 201 has a handle whichis long enough to support a scale and/or reference mark that aligns withsome visible part of the second dilator (a scale mark, distal end, orindicator mark) when the cannula 201 is in place. Additionally oralternatively, the cannula insertion depth is controlled/monitoredrelative to the total vaginal length.

At block 565, the second dilator is removed. Cannula 201 is nowpositioned crossing the rectouterine wall, and at a known longitudinaldepth relative to the rectouterine wall.

Optionally, the stepped dilator 1100 of FIGS. 11A-11E is used by thismethod, with the insertion of FIG. 6E optionally occurring in twostages, one for each of distal tapering region 1121, and proximaltapering region 1117, optionally with a pause between the two stagesenabled by allowing the physician to sense a change in insertionresistance upon transitioning from distal tapering region 1121 toisolating region 1119.

Cannula Fixation and Robot Alignment to Cannula

Free-Positioned Alignment System

Reference is now made to FIGS. 9A-9D, which comprise views representingan instrument holder 900 for cannula 201 and its configuration for use,wherein instrument holder 900 includes a motor unit stopper 902 for usein setting an initial robotic arm position, according to someembodiments of the present disclosure.

FIG. 9A schematically shows an in instrument holder 900, comprising amounting block 901 and a stopper arm 902. In some embodiments, stopperarm 902 is hinged upon hinge 904 to rotate to different orientationsrelative to mounting block 901.

FIG. 9B shows cannula 201 and associated handle 202 mounted to mountingblock 901. Mounting, in some embodiments, comprises positioning aproximal end of handle 202 in a well-defined position relative tomounting block 901; for example, flush with an aperture 903 of a lumenwithin block 901 sized and shaped to receive handle 202. Fixation ofcannula 201 relative to block 901 is optionally assured by tightening atightening handle 905.

FIG. 9C shows an overall mounting arm assembly 910, comprising atable-mounting block 911 (configured, e.g., with clamps and tighteninghandles supporting firm attachment to a table or other stabilizingsurface), and jointed arm 912 extending distally from the mounting block911 to attachment at its distal side to mounting block 901.

FIG. 9D shows the instrument holder 900 with motor unit stopper 902configured to set an initial working distance of motor unit 930. Motorunit stopper 902 is sized so that when positioned to horizontallyprotrude from block 901, its distal end marks the distance at whichmotor unit 930 should be set so that its arms (which themselves have awell-known predetermined length) reach a defined (and safe) initialdistal-most position within cannula 201 (e.g., at the distal end of thecannula) when cannula 201 positioned relative to mounting block 901 asshown in FIG. 9B (the cannula is not shown in FIG. 9D). Robotic arms 305(not seen) pass distally from motor unit 930 within extenders 920.Extenders 920 comprise tubes having a lumen sized to pass the roboticarms 305 thereinto, for example, a lumen of, for example, at least 7 mm,8 mm, 9 mm, or 10 mm. Extenders 920 may be aligned (e.g., set withinslots 921 of FIG. 9B) to guide the robotic arms 305 to cannula 201.

By appropriate positioning of its parts at marked and predeterminedpositions, a kit comprising cannula 201 and handle 202, and instrumentholder 900 with motor unit stopper 902 (optionally including extenders920 and/or motor unit 930 and associated arms 305) potentially helps toachieve a rapid, reproducible initial setup providing a well-determinedinitial relationship between the distal end of cannula 201, and thedistal ends of robotic arms 305, for example, an alignment of the twoends.

To allow initiation of robotic arm movement in a distal direction, motorunit stopper 902 is allowed to swing away from the horizontal position(e.g., downward), so that motor unit 930 can advance distally withoutinterference. Preferably, attachment of motor unit stopper 902 to block901 is configured to allow conversion between a first position thatprevents advance of motor unit 930, and a second position that allowsit; without disturbing the position of structures on either side ofit—for example, without disturbing positions of the cannula 201 or themotor unit 930. The attachment is not necessarily by a hinge (forexample, stopper 902 may be telescoping, slideable within block 901, orotherwise moveable). A hinge provides a potential advantage by allowinga reproducible longitudinal stopper position to be obtained when thestopper is oriented in the horizontal (oriented to the longitudinal axisof the cannula) position, together with ready conversion to anon-stopping position without having to exert either longitudinal forceto slide the stopper 902, or torque on a fastener to release the stopper902.

Lock-Positioned Alignment System

Reference is now made to FIGS. 10A-10E, which schematically illustrateviews representing a collapsing instrument holder 1000 for cannula 1010and its configuration for use in setting an initial robotic arm positionrelative to cannula 1010, according to some embodiments of the presentdisclosure. Reference is also made to FIGS. 10F-10J, which schematicallyrepresent components of collapsing instrument holder 1000, according tosome embodiments of the present disclosure. Further reference is made toFIGS. 12A-12C, which schematically represent a duck-bill gasket 1050used to seal access to the proximal aperture of access device 1001,according to some embodiments of the present disclosure.

FIG. 10A shows an access device 1001, shaped for insertion into a gelseal 1003 (in a position indicated, for example, in FIGS. 10B-10C). Inuse, gel seal 1003 is positioned at the vaginal entrance to provideprotected access; thus, elements positioned to the right of gel seal1003 would be positioned intra-vaginally during a procedure, andelements positioned to the left would be positioned extra-vaginally.

Trans-seal region 1001A of access device 1001 is flanged on either side,and seats within the gel membrane of gel seal 1003. External (proximal)side 1001B of access device 1001 (also referred to herein as a“trocar”), in some embodiments, is provided with a mounting projection1002. Lumen 1004 of access device 1001 is sized to allow insertion ofstepped dilator 1100 (e.g., as shown in FIG. 10B), or optionally anotherdilator/dilator system, for example, a two-piece dilator comprisinginner dilator 205 and outer dilator 203. Also shown in Figure JOBassembled together with stepped dilator 1100 are needle handle 511 ofneedle 207 and dilator handle 510.

Lumen 1004 of access device 1001 is also sized to allow insertion of acannula 1010 over stepped dilator 1100 (or other dilatory system). Wheninserted to lumen 1004, in some embodiments, cannula 1010 is fittinglycontained by access device 1001, and optionally locked thereto. Cannula1010, in some embodiments, comprises a body with an elongated (e.g.,oval) cross-section, having a slanted distal aperture 209, for exampleas described in relation to FIG. 3L, and a flange 221 at its proximalside. In some embodiments, flange 221 includes a receiving indentationfor a ball stop 1006 provided on access device 1001 which controlsrelative motion between cannula 1010 and access device 1001 when locked.

In some embodiments, a two-seal “duck bill” gasket 1050 (shown in FIG.10C, and FIGS. 12A-12C) is inserted into the proximal aperture of accessdevice 1001 after positioning of cannula 1010. A first sealing member1050A of gasket 1050 is normally sealed (two opposite sides pushedtogether) when there is nothing inserted into cannula 1010. Uponinsertion of robotic arm guide 1032 (explained further in relation toFIGS. 10D-10E), first sealing member 1050A is forced open, while asecond sealing member 1050B, which is normally open, is shaped so thatit seals around the robotic arm guide 1032. The sealing members 1050A,1050B are made of a soft elastic material, for example, a siliconerubber. In some embodiments, gasket body 1050C comprises a rigid polymeror metal material that provides support to sealing members 1050A, 1050Bto help maintain the overall shape of gasket 1050. In some embodiments,each of the sealing members 1050A, 1050B is shaped so that it has a longaxis and a short axis, with the long axis being at least twice as longas the short axis.

The placement of the above-described elements generally corresponds, insome embodiments, to the operations of block 120 (dilate and introducecannula) and block 122 (sealing unit) of FIG. 3J.

Fixation corresponding to operation of block 124 of FIG. 3J, in someembodiments, comprises attaching mounting projection 1002 to mountingblock 1020. Mounting block 1020 may itself be affixed, for example, to aplatform stationary relative to the patient, such as an operating table.In some embodiments, attachment comprises insertion of mountingprojection 1002 into a receiving aperture 1061 (shown in FIG. 10J) ofmounting block 1020. In some embodiments, notch 1005 or another shape onmounting projection 1002 engages to a lock within receiving aperture1061. Optionally, button 1021 is pressed to assist and/or activateengagement and/or release of mounting projection 1002 from the lock.

Mounting block 1020 is a component of instrument holder 1000. Attachedto mounting block 1020, instrument holder 1000 additionally comprisesspacing arm 1024 and aligning arm 1030. In some embodiments, spacing arm1024 is attached to mounting block 1020 by stopped hinge 1022, andaligning arm 1030 is in turn attached to spacing arm 1024 by stoppedhinge 1028. In some embodiments, spacing arm 1024 is telescoping(reversibly extendible and retractable). Optionally, release and/orlocking of telescoping is controlled by a button 1026 or other controlmember.

The use of stopped hinges 1022, 1028 and button 1026 to position spacingarm 1024 and aligning arm 1030 are further illustrated in FIGS. 10D-10E.

In some embodiments of the invention, cannula 1010 is used to provideintraperitoneal access to one or more robotic arms, for example roboticarms 305 as described, for example, in relation to FIGS. 3I and 7A-7B.As also described in the Overview herein, it is a potential advantage tobe able to position these robotic arms so that they begin at awell-known distance of longitudinal advance through cannula 1010, and ata well-known angle of approach (generally an angle of approach axiallyaligned with cannula 1010).

In FIGS. 10D-10E, spacing arm 1024 and aligning arm 1030 comprise anassembly shown fully deployed (in a deployed position) in order to helpset a starting position for robotic arms being introduced into cannula1010. In some embodiments, this comprises:

-   -   Rotating spacing arm 1024 90° from its vertically downward        stowed position (seen in FIG. 10C) to a horizontal deployment        position.    -   Extending spacing arm 1024 to set the spacing distance by        pressing on button 1026, and pulling to expose telescoping arm        portion 1024A.    -   Rotating aligning arm 130 from its stowed position against        spacing arm 1024 (as in FIG. 10C) to a vertical deployment        position.

Optionally, spacing arm 1024 and aligning arm 1030 are returned to theirstowed positions after use to position robotic arms correctly. Apotential advantage of post-use stowing is so that they do not interferewith further movements of the robotic arms (e.g., advancing deeper intothe intraperitoneal cavity).

FIGS. 10F-10J illustrate these components in more detail. FIGS. 10F-10Hshow spacing arm 1024 in a collapsed (unextended) configuration. Stoppedhinges 1022, 1028 can be seen, including details of an optionalembodiment thereof. For example, in the case of stopped hinge 1022, eachof (optionally four) projections 1063 is spaced around a circumferenceof stopped hinge 1022. Each projection 1063 extends into a respectivenotch of plate 1022A. The projections 1063 are fixed to the orientationof block 1020 (FIG. 10J), while plate 1022A is affixed to spacing arm1024. Accordingly, as long as the projections 1063 engage the notches ofplate 1022A, spacing arm 1024 is fixed in orientation. Upon actuatingbutton 1062, projections 1063 are recessed out of their notches,allowing spacing arm 1024 to rotate freely. Optionally, the projections1063 are held in place by plate 1022A once the notches are moved out ofalignment with them, so that button 1022A can be released while spacingarm 1024 continues to move freely.

Once spacing arm 1024 is deployed by a full 90°, the notches of plate1022A and projections 1063 come back into alignment, allowingprojections 1063 to spring back into place, locking spacing arm 1024 ina new orientation. This mechanism has potential advantages of (1) onlyallowing one deployed orientation of spacing arm 1024, and (2) beingstrong enough to hold the horizontally deployed weight of spacing arm1024 and aligning arm 1030 without collapsing.

Stopped hinge 1028, in some embodiments, comprises a similar mechanism,comprising projections 1065, button 1067, and notched plate 1066.Notched plate 1066 is again affixed to spacing arm 1024, while theprojections 1065 are fixed to the orientation of aligning arm 1030.

In the fully deployed position of FIGS. 10D-10E, horizontal bar 1068(FIG. 101) of aligning arm 1030 acts to set an elevation across whichrobotic arms should be horizontally passed while aiming at cannula 1010in order to be level with the longitudinal axis of cannula 1010.Similarly, the robotic arms should pass through the space betweenvertical bars 1064 in order to approach cannula 1010 along its centrallongitudinal axis. Furthermore, in some embodiments, a motor unit orother housing holding a robotic arm which is being positioned is inposition when some designated portion of it (a “stopper-receivingportion”) is pressed up against a portion of aligning arm 1030 that actsas a stopper, for example, pressed against the vertically extending mainbar 1069 of aligning arm 1030.

Returning now to FIGS. 10D-10E: in some embodiments, robotic arms 305are sheathed (e.g., two round arms side-by-side) using arm sheath 1032before being passed into cannula 1010 (e.g., in performing theoperations of block 126 of FIG. 3.1). In some embodiments, arm sheath1032 has an inner lumen sized to allow at least two robotic arms havinga minimum outer diameter of about 8.6 mm to pass therethrough. In someembodiments, for example, a minimum diameter of the inner lumen of armsheath 1032 is about 9 mm, 10 mm, or 11 mm.

A potential advantage of sheath 1032 is to ensure that the arms arestraight, and moreover to ensure that no part of them will beaccidentally snagged during passage into and through cannula 1010. Insome embodiments, moreover, there is provided a gasket 1034, comprisinga fitted hole for each of two robotic arms that may be passedtherethrough. Gasket 1034 fittingly attaches to a proximal end of armsheath 1032, to act as another protective seal. Optionally, arm sheath1032 is constructed from stainless steel. Optionally gasket 1034 ismanufactured from a flexible polymer such as a silicone rubber.

Stepped Dilator

Reference is now made to FIGS. 11A-11E, which schematically represent astepped dilator 1100, dilator handle 510, and trocar needle 207,according to some embodiments of the present disclosure. Reference

Dilator handle 510 and trocar needle 207 are, in some embodiments,substantially as described, for example, in relation to FIGS. 5D-5F, 5H,5I, and 5K.

In some embodiments, stepped dilator 1100 comprises, along a distalworking end 1115 of a single dilator, distal and proximal taperingregions 1121 and 1117 (FIGS. 11B, 11C). Distal and proximal taperingregions 1121, 1117 are, in some embodiments, substantially shaped asdescribed for embodiments of tapering regions 213 and 218 of thetwo-dilator combination which is described herein, for example, inrelation to FIGS. 2A-3I and 5K. Nevertheless, some specific details oftapering region shapes are repeated here for clarity.

In some embodiments, distal (first) tapering region 1121 has a blunteddistal-most portion. The distal-most portion optionally has a portthrough which a trocar needle 207 can be extended. Optionally, thedistal-most portion curves proximally, widening in both width and heightthrough a radius of about 2.5 mm, then expanding primarily in width toform a wide oblong cross-section about 15 mm proximal to the distal-mostportion (or another distance, for example in the range of about 10-20mm).

In some embodiments, a non-dilating isolating region 1119 extendslongitudinally between the distal and proximal tapering regions.Preferably, isolating region 1119 is long enough to allow an insertingphysician to sense a reduction in insertion resistance upon passing theproximal side of distal tapering region 1121, and reduce insertion forcein response, so that dilation is paused. This distance is optionally inthe range of about 5-15 mm. In some embodiments, isolating region 1119is of a constant cross-section extending proximally from the distal sideof isolating region 1119 until reaching the distal side of proximaltapering region 1117. Alternatively, isolating region 1119A (FIG. 11C),in some embodiments, comprises a constriction (e.g., a taperingconstriction) relative to the proximal-side cross-section of distaltapering region 1121, which potentially acts as a detente thataccentuates for a physician the sensation of reduced insertionresistance. The constriction may also allow a physician to detect byfeel a difference between an initial dilation after which the dilatedtissue perimeter retains elasticity (tending to re-collapse the dilatedopening), and a dilation where a tear has been induced, potentiallyreducing the tendency of the dilated opening to exert inward force onthe dilator.

In some embodiments, proximal (second) tapering region 1117 has adistal-most cross-section arising from the proximal-most portion ofisolating region 1119. From there, the second dilator's cross-sectionexpands going proximally for about 15 mm (or another distance, forexample in the range of about 10-20 mm). The maximum of the furtherexpansion is an expansion by about, for example, about 5 mm, 7.5, mm, 10mm, or 12.5 mm. Optionally, there is a larger expansion along one axisof the incision cross-section than along another axis; for example,there may be a relative factor of expansion of about 1:1.5, 1:2, or 1:3.

In some embodiments, a body 1111 of dilator 1100 is constructed of asterilizable and re-sterilizable (e.g., autoclave compatible) material,e.g. stainless steel. Optionally, an inset region 1113 is provided onone or both sides of body 1111. This potentially reduces weight ofdilator 1100 (e.g., in embodiments where body 1111 is constructed of asolid piece of metal).

In some embodiments, dilator 1100 is at least 17 cm in overall lengthwithout handle 510. In some embodiments, threaded region 1102A isthreaded to accept a thread of handle 510. Handle 510 is optionally atleast 20 cm long.

General

As used herein with reference to quantity or value, the term “about”means “within ±10% of”.

The terms “comprises”, “comprising”, “includes”, “including”, “having”and their conjugates mean: “including but not limited to”.

The term “consisting of” means: “including and limited to”.

The term “consisting essentially of” means that the composition, methodor structure may include additional ingredients, steps and/or parts, butonly if the additional ingredients, steps and/or parts do not materiallyalter the basic and novel characteristics of the claimed composition,method or structure.

As used herein, the singular form “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. For example,the term “a compound” or “at least one compound” may include a pluralityof compounds, including mixtures thereof.

The words “example” and “exemplary” are used herein to mean “serving asan example, instance or illustration”. Any embodiment described as an“example” or “exemplary” is not necessarily to be construed as preferredor advantageous over other embodiments and/or to exclude theincorporation of features from other embodiments.

The word “optionally” is used herein to mean “is provided in someembodiments and not provided in other embodiments”. Any particularembodiment may include a plurality of “optional” features except insofaras such features conflict.

As used herein the term “method” refers to manners, means, techniquesand procedures for accomplishing a given task including, but not limitedto, those manners, means, techniques and procedures either known to, orreadily developed from known manners, means, techniques and proceduresby practitioners of the chemical, pharmacological, biological,biochemical and medical arts.

As used herein, the term “treating” includes abrogating, substantiallyinhibiting, slowing or reversing the progression of a condition,substantially ameliorating clinical or aesthetical symptoms of acondition or substantially preventing the appearance of clinical oraesthetical symptoms of a condition.

Throughout this application, embodiments of this disclosure may bepresented with reference to a range format. It should be understood thatthe description in range format is merely for convenience and brevityand should not be construed as an inflexible limitation on the scope ofthe disclosure. Accordingly, the description of a range should beconsidered to have specifically disclosed all the possible subranges aswell as individual numerical values within that range. For example,description of a range such as “from 1 to 6” should be considered tohave specifically disclosed subranges such as “from 1 to 3”, “from 1 to4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; aswell as individual numbers within that range, for example, 1, 2, 3, 4,5, and 6. This applies regardless of the breadth of the range.

Whenever a numerical range is indicated herein (for example “10-15”, “10to 15”, or any pair of numbers linked by these another such rangeindication), it is meant to include any number (fractional or integral)within the indicated range limits, including the range limits, unlessthe context clearly dictates otherwise. The phrases“range/ranging/ranges between” a first indicate number and a secondindicate number and “range/ranging/ranges from” a first indicate number“to”, “up to”, “until” or “through” (or another such range-indicatingterm) a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numbers therebetween.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

All publications, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by referenceinto the specification, to the same extent as if each individualpublication, patent or patent application was specifically andindividually indicated to be incorporated herein by reference. Inaddition, citation or identification of any reference in thisapplication shall not be construed as an admission that such referenceis available as prior art to the present invention. To the extent thatsection headings are used, they should not be construed as necessarilylimiting.

It is appreciated that certain features, which are, for clarity,described in the context of separate embodiments within the presentdisclosure, may also be provided in combination in a single embodiment.Conversely, various features, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the present disclosure. Certain features described in thecontext of various embodiments are not to be considered essentialfeatures of those embodiments, unless the embodiment is inoperativewithout those elements.

What is claimed is:
 1. A method of using a cannula to provideintraperitoneal access to a body cavity via a body recess, comprising:inserting a distal end of the cannula into a dilated aperture of arectouterine pouch via transvaginal access, an internal lumen of saidcannula sized to accept a plurality of flexible robotic arms to bepassed therethrough; wherein an edge defining an aperture at the distalend of the cannula comprises a first edge portion extending along oneside of the aperture, and a second edge portion extending along anopposite side of the aperture, and the first edge portion is positionedmore distally along the cannula and from the dilated aperture than thesecond edge portion; wherein said inserting comprises orienting thecannula so that the aperture at the distal end of the cannula isoriented to open toward the side of the second edge portion and facingtoward a rectum adjacent to the rectouterine pouch; and introducing saidplurality of flexible robotic arms through said cannula, said pluralityof robotic arms extending side-by-side along said internal lumen; upon adistal portion of at least one of said plurality of flexible roboticarms exiting the cannula aperture, bending at least said distal portionacross a plane of said first edge portion of the cannula aperture andinto the intraperitoneal space, such that at least said distal portioncurves downward from the cannula aperture, oriented away from the rectumand towards the intraperitoneal space; and further advancing said atleast one of said plurality of flexible robotic arms, when bent, deeperinside the intraperitoneal space.
 2. The method of claim 1, whereininserting a distal end of the cannula into the rectouterine pouchcomprises sliding the cannula over a dilator, which is inserted into therectouterine pouch via transvaginal access.
 3. The method of claim 1,wherein: inserting a distal end of the cannula into the rectouterinepouch comprises sliding the cannula over a stepped dilator; the steppeddilator has a tapered distal insertion end with a rounded tip, a secondtapered region, and an isolating region between the second taperedregion and the tapered distal insertion end; the cannula slidesfittingly over the stepped dilator; and the stepped dilator is insertedinto the rectouterine pouch via transvaginal access.
 4. The method ofclaim 3, wherein the rounded tip has a hole sized to pass a trocarneedle having a diameter less than or equal to about 2 mm.
 5. The methodof claim 4, comprising passing said trocar needle through said hole ofthe stepped dilator to form an aperture in a wall of the rectouterinepouch.
 6. The method of claim 5, comprising controlling advancement ofsaid trocar needle using a stopper.
 7. The method of claim 5, comprisingwidening said aperture in the wall of the rectouterine pouch byadvancing said stepped dilator over said trocar needle.
 8. The method ofclaim 7, comprising retracting said trocar needle before or duringadvancement of said stepped dilator.
 9. The method of claim 7,comprising advancing said cannula over said stepped dilator through thewidened aperture in the wall of the rectouterine pouch.
 10. The methodof claim 1, wherein said plurality of flexible robotic arms are receivedwithin a sheath sized to fit within said cannula.
 11. The method ofclaim 1, comprising, prior to said inserting of said cannula, placing asealing unit and a trocar at a vaginal orifice.
 12. The method of claim11, comprising fixating at least one of said cannula and said sealingunit to a platform which is stationary relative to a patient.
 13. Themethod of claim 1, wherein a cross section of said internal lumen ofsaid cannula has a long axis and a short axis; and wherein the long axisis at least twice as long as the short axis.
 14. The method of claim 13,wherein said long axis is sized to allow insertion of at least twoflexible robotic arms side-by-side, each flexible robotic arm having adiameter of 8 mm.
 15. The method of claim 1, wherein said plurality offlexible robotic arms are two flexible robotic arms.
 16. A method ofusing a cannula to access an intraperitoneal space via a vagina,comprising: introducing a trocar needle transvaginally to penetrate awall of a rectouterine pouch, said trocar needle nested within adilator; dilating an aperture formed by the penetration by advancingsaid dilator over said trocar needle, said dilator at least partiallynested within a cannula, an internal lumen of said cannula sized toaccept one or more flexible robotic arms to be passed therethrough;wherein an edge defining an aperture at a distal end of the cannulacomprises a first edge portion extending along one side of the cannulaaperture, and a second edge portion extending along an opposite side ofthe cannula aperture, and the first edge portion is positioned moredistally along the cannula than the second edge portion; advancing saidcannula over said dilator; orienting the cannula so that said apertureat the distal end of the cannula is oriented to open toward the side ofthe second edge portion and facing toward a rectum adjacent to therectouterine pouch; introducing one or more flexible robotic armsthrough the lumen of the cannula so that at least a distal portion ofsaid one or more robotic arms reaches into the intraperitoneal space;upon said distal portion exiting the cannula aperture, bending at leastsaid distal portion across a plane of said first edge portion of thecannula aperture and into the intraperitoneal space, such that at leastsaid distal portion curves downward from the cannula aperture; andfurther advancing said one or more robotic arms, when bent, deeper intothe intraperitoneal space.
 17. The method of claim 16, comprisingcontrolling movement of said one or more flexible robotic arms toperform surgical activity in the intraperitoneal space.
 18. The methodof claim 16, comprising resisting over-advancing of a distal tip of saidtrocar needle beyond a distal tip of said dilator using a stopper. 19.The method of claim 16, comprising inserting at least one of a cameraand an illumination source into the intraperitoneal space.
 20. Themethod of claim 16, wherein said dilator is a stepped dilator comprisinga distal tapering region and a proximal tapering region; and whereinsaid dilating is performed in two stages, allowing a physician to sensea change in insertion resistance.
 21. The method of claim 16, comprisingsheathing said one or more flexible robotic arms side by side within asingle sheath sized to fit within said cannula.